Halyard 13472Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10680651134728), received between Feb 20, 2017 and May 26, 2020 — classified as 18 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (33 reports).

3 other recalls cover devices cleared under the same FDA submission (K063530); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED 27-MAY-2020 INDICATED THE PATIENT'S INFUSION BEGAN (B)(6) 2020 1730 AND ENDED (B)(6) 2020 1730. BLISTERS WERE NOTICED ON (B)(6) 2020 AND NECROSIS DEVELOPED LATER, DATE UNKNOWN. THE CATHETER WAS AN EPIDURAL CATHETER, BRAND UNKNOWN. TOTAL FILL VOLUME OF THE PUMP WAS 400ML AND IT WAS SET TO A FLOW RATE OF 8ML/HR. PATIENT RECEIVED GENERAL ANESTHESIA PLUS BLOCK. CATHETER LOCATION WAS "MEDIAL FEMORAL CONDYLE, TIP TUCKED POSTERIOR OF THE KNEE." SURGEON NOTED THE INCIDENT. PATIENT NEEDED A "SKIN GRAFT AND PLASTIC SURGEON PRESENCE." THE PATIENT WAS AMBULATORY WHILE USING THE PUMP. PATIENT'S CURRENT CONDITION WAS LISTED AS "REPAIR SURGERY HAS OCCURRED." ADDITIONAL INFORMATION RECEIVED 02-JUN-2020 INDICATED THE PUMP WAS FILLED AND PRIMED ACCORDING TO THE INSTRUCTIONS FOR USE. THE SURGEON WANTED TO TRIAL ADDING THE FOUR DRUGS MENTIONED IN THE INITIAL REPORT [TRANEXAMIC ACID, ADRENALINE, CELESTONE, KETOROLAC ] TO THE LOCAL ANESTHETIC IN THE PUMP TO SEE IF THIS IMPROVED THE PATIENT OUTCOME. THE HOSPITAL HAD TWO SURGEONS USING THE ON-Q PUMPS PRIOR TO THIS SURGEON'S TRIAL. STAFF WAS TRAINED. PATIENT WAS A NEW USER OF THE PUMP. THE SURGEON STATED HE "STITCHES [STITCH

  Patient problems: Necrosis

  MAUDE report 10089381 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED 27-MAY-2020 INDICATED THE PATIENT'S INFUSION BEGAN (B)(6) 2020 1100 AND ENDED (B)(6) 2020 1700. BLISTERS WERE NOTICED ON 02-MAR-2020 AND NECROSIS DEVELOPED LATER, DATE UNKNOWN. THE CATHETER WAS AN EPIDURAL CATHETER, BRAND UNKNOWN. TOTAL FILL VOLUME OF THE PUMP WAS 550ML AND IT WAS SET TO A FLOW RATE OF 6ML/HR. PATIENT RECEIVED GENERAL ANESTHESIA PLUS BLOCK. CATHETER LOCATION WAS "MEDIAL FEMORAL CONDYLE, TIP TUCKED POSTERIOR OF THE KNEE." SURGEON NOTED THE INCIDENT. PATIENT NEEDED TO UNDERGO FURTHER SURGERY; A MUSCLE FLAT TO REPLACE THE NECROTIC MUSCLE AND A SKIN GRAFT TO COVER WOUND. THE PATIENT WAS AMBULATORY WHILE USING THE PUMP. PATIENT'S CURRENT CONDITION WAS LISTED AS "PATIENT HAS UNDERGONE REPAIR SURGERY." ADDITIONAL INFORMATION RECEIVED 02-JUN-2020 INDICATED THE PUMP WAS FILLED AND PRIMED ACCORDING TO THE INSTRUCTIONS FOR USE. THE SURGEON WANTED TO TRIAL ADDING THE FOUR DRUGS MENTIONED IN THE INITIAL REPORT [TRANEXAMIC ACID, ADRENALINE, CELESTONE, KETOROLAC ] TO THE LOCAL ANESTHETIC IN THE PUMP TO SEE IF THIS IMPROVED THE PATIENT OUTCOME. THE HOSPITAL HAD TWO SURGEONS USING THE ON-Q PUMPS PRIOR TO THIS SURGEON'S TRIAL. STAFF WAS TRAINED. PATIE

  Patient problems: Necrosis

  MAUDE report 10089380 ↗
• InjuryMar 26, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2020-00042 FOR THE FIRST EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4 ML/HR. PROCEDURE: ENDOSCOPIC CARPAL TUNNEL WITH ULNAR NERVE REPAIR. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT USED THE ELASTOMERIC PUMP FOR A ELBOW/ULNAR PROCEDURES. THE PUMP INFUSED AT 4ML/HR. THE PATIENT CAME INTO THE CLINIC WITH NO PAIN BUT WAS SWOLLEN WITH NEUROPRAXIAS. THE PATIENT WILL BE GOING TO THE OCCUPATIONAL THERAPY (OT) AND THERAPY FOR THE EDEMA. ADDITIONAL INFORMATION RECEIVED 18-MAR-2020 STATED THE PRODUCT WAS USED IN ACCORDANCE WITH INSTRUCTIONS. THE USER OR FACILITY CONDITIONS DID NOT CONTRIBUTE TO THE INCIDENT. THE DRUG WAS NOT A CONTRIBUTOR OR POTENTIAL CONTRIBUTOR TO THE INCIDENT.

  Patient problems: Edema; No Code Available

  MAUDE report 9882555 ↗
• InjuryMar 26, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2020-00043 FOR THE SECOND EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4 ML/HR. PROCEDURE: ENDOSCOPIC CARPAL TUNNEL WITH ULNAR NERVE REPAIR. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT USED THE ELASTOMERIC PUMP FOR A ELBOW/ULNAR PROCEDURES. THE PUMP INFUSED AT 4ML/HR. THE PATIENT CAME INTO THE CLINIC WITH NO PAIN BUT WAS SWOLLEN WITH NEUROPRAXIAS. THE PATIENT WILL BE GOING TO THE OCCUPATIONAL THERAPY (OT) AND THERAPY FOR THE EDEMA. ADDITIONAL INFORMATION RECEIVED 18-MAR-2020 STATED THE PRODUCT WAS USED IN ACCORDANCE WITH INSTRUCTIONS. THE USER OR FACILITY CONDITIONS DID NOT CONTRIBUTE TO THE INCIDENT. THE DRUG WAS NOT A CONTRIBUTOR OR POTENTIAL CONTRIBUTOR TO THE INCIDENT.

  Patient problems: Edema; No Code Available

  MAUDE report 9882549 ↗
• InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 540 ML. FLOW RATE: 8 ML/HR. PROCEDURE: HYSTERECTOMY. CATHPLACE: SUPERIOR TO PELVIC SYMPHYSIS. INFUSION START TIME: (B)(6) 2020 14:00. INFUSION STOP TIME: (B)(6) 2020 22:00. IT WAS REPORTED THAT THE PATIENT CAME "TO THE EMERGENCY DEPARTMENT AND WAS ADMITTED TO THE HOSPITAL. [THE PATIENT] COMPLAINED OF ABDOMINAL PAIN AND WAS FOUND TO HAVE A FEVER." THE USER FACILITY STATED THAT IT WAS BELIEVED THE PATIENT "MAY HAVE HAD A POSSIBLE PELVIC INFECTION RELATED TO THE PUMP." ADDITIONAL INFORMATION RECEIVED 30-JAN-2020 INCLUDED PATIENT DEMOGRAPHICS. THE TREATMENT/INTERVENTION PERFORMED WAS "BROAD-SPECTRUM ANTIBIOTICS TREATMENT." PATIENT OUTCOME WAS LISTED AS "RECOVERED." PATIENT DIAGNOSIS WAS "POSTOPERATIVE FEVER" WITH SYMPTOMS OF GENERALIZED ABDOMINAL PAIN, CHILLS, TREMORS, MILD FEVER. THE PHYSICIAN "BELIEVES THE [DEVICE] MAY POSSIBLY BE RELATED TO THE POST-OPERATIVE FEVER RESULTING IN HOSPITALIZATION. THE PATIENT EXPRESSED A DECREASE IN SYMPTOMS TEMPORARILY UPON REMOVAL OF THE CATHETER. POST-OPERATIVE INFECTIONS DO NOT TYPICALLY OCCUR AS EARLY AS THIS PATIENT'S INCIDENT." "APPROXIMATELY 48 HOURS AFTER THE PUMP WAS PLACED, AT AROUND 6PM ON (B)(6) 2020 THE PATIENT EXPERIENCED CH

  Patient problems: Abdominal Pain; Chills; Fever; Shaking/Tremors

  MAUDE report 9717599 ↗
• InjuryJan 16, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 10 ML/HR. PROCEDURE: TOTAL KNEE ARTHROPLASTY. CATHPLACE: ADDUCTOR CANAL CATHETER. IT WAS REPORTED THE PUMP DELIVERED A LARGE OVERDOSE OF ROPIVACAINE CREATING LEG NUMBNESS THAT RESOLVED 1-HOUR TO 2-HOURS AFTER INFUSION WAS STOPPED. ADDITIONAL INFORMATION WAS RECEIVED ON 27-DEC-2019 VIA MEDWATCH/ FDA USER FACILITY REPORT NUMBER, MW 5091377 EVENT DESCRIPTION: PT [PATIENT] EXPERIENCED ALMOST TOTAL LOSS OF SENSATION AND MOTOR FUNCTION IN LEG BELOW THE KNEE WHILE A PAIN PUMP WAS RUNNING. THE PUMP WAS ATTACHED TO AN ADDUCTOR CANAL CATHETER, WHICH HAD BEEN FUNCTIONING NORMALLY THE NIGHT BEFORE WITH ONLY MILD NUMBNESS AT THAT TIME. WHEN SHE WOKE UP ON POSTOPERATIVE DAY1 AFTER TOTAL KNEE ARTHROPLASTY, HER LEG WAS VERY NUMB, SHE HAD MINIMAL MOTOR FUNCTION, AND LOSS OF PROPRIOCEPTION IN THAT LEG. PUMP WAS SET AT 10 ML/HOUR AND NOT CHANGED THROUGHOUT THE PROCESS. NO LEAKAGE NOTED. DIAGNOSIS FOR USE POSTOPERATIVE PAIN IN KNEE.-CR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Numbness

  MAUDE report 9595636 ↗
• MalfunctionDec 13, 2019Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED 16-DEC-2019 STATED: THIS EVENT HAS BEEN CONFIRMED AS DUPLICATE OF REPORT NUMBER 2026095-2019-00195. ANY ADDITIONAL INFORMATION RECEIVED WILL BE FILED UNDER REPORT NUMBER 2026095-2019-00195. NO FURTHER REPORTS WILL BE FILED UNDER REPOT NUMBER 2026095-2019-00201.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9470324 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE EIGHTH OF EIGHT REPORTS. REFER TO 2026095-2019-00166 FOR THE FIRST EVENT. REFER TO 2026095-2019-00167 FOR THE SECOND EVENT. REFER TO 2026095-2019-00168 FOR THE THIRD EVENT. REFER TO 2026095-2019-00169 FOR THE FOURTH EVENT. REFER TO 2026095-2019-00170 FOR THE FIFTH EVENT. REFER TO 2026095-2019-00171 FOR THE SIXTH EVENT. REFER TO 2026095-2019-00172 FOR THE SEVENTH EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4ML/HR-6ML/HR. PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LEAV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240883 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE SEVENTH OF EIGHT REPORTS. REFER TO 2026095-2019-00166 FOR THE FIRST EVENT. REFER TO 2026095-2019-00167 FOR THE SECOND EVENT. REFER TO 2026095-2019-00168 FOR THE THIRD EVENT. REFER TO 2026095-2019-00169 FOR THE FOURTH EVENT. REFER TO 2026095-2019-00170 FOR THE FIFTH EVENT. REFER TO 2026095-2019-00171 FOR THE SIXTH EVENT. REFER TO 2026095-2019-00173 FOR THE EIGHTH EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4ML/HR-6ML/HR. PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LEAV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240882 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE FOURTH OF EIGHT REPORTS. REFER TO 2026095-2019-00166 FOR THE FIRST EVENT. REFER TO 2026095-2019-00167 FOR THE SECOND EVENT. REFER TO 2026095-2019-00168 FOR THE THIRD EVENT. REFER TO 2026095-2019-00170 FOR THE FIFTH EVENT. REFER TO 2026095-2019-00171 FOR THE SIXTH EVENT. REFER TO 2026095-2019-00172 FOR THE SEVENTH EVENT. REFER TO 2026095-2019-00173 FOR THE EIGHTH EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4ML/HR-6ML/HR. PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LEAV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240876 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE SIXTH OF EIGHT REPORTS. REFER TO 2026095-2019-00166 FOR THE FIRST EVENT. REFER TO 2026095-2019-00167 FOR THE SECOND EVENT. REFER TO 2026095-2019-00168 FOR THE THIRD EVENT. REFER TO 2026095-2019-00169 FOR THE FOURTH EVENT. REFER TO 2026095-2019-00170 FOR THE FIFTH EVENT. REFER TO 2026095-2019-00172 FOR THE SEVENTH EVENT. REFER TO 2026095-2019-00173 FOR THE EIGHTH EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4ML/HR-6ML/HR. PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LEAV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240875 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE FIFTH OF EIGHT REPORTS. REFER TO 2026095-2019-00166 FOR THE FIRST EVENT. REFER TO 2026095-2019-00167 FOR THE SECOND EVENT. REFER TO 2026095-2019-00168 FOR THE THIRD EVENT. REFER TO 2026095-2019-00169 FOR THE FOURTH EVENT. REFER TO 2026095-2019-00171 FOR THE SIXTH EVENT. REFER TO 2026095-2019-00172 FOR THE SEVENTH EVENT. REFER TO 2026095-2019-00173 FOR THE EIGHTH EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4ML/HR-6ML/HR. PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LEAV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240873 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE SECOND OF EIGHT REPORTS. REFER TO 2026095-2019-00166 FOR THE FIRST EVENT. REFER TO 2026095-2019-00168 FOR THE THIRD EVENT. REFER TO 2026095-2019-00169 FOR THE FOURTH EVENT. REFER TO 2026095-2019-00170 FOR THE FIFTH EVENT. REFER TO 2026095-2019-00171 FOR THE SIXTH EVENT. REFER TO 2026095-2019-00172 FOR THE SEVENTH EVENT. REFER TO 2026095-2019-00173 FOR THE EIGHTH EVENT. FILL VOLUME: 400 ML. FLOW RATE: 4ML/HR-6ML/HR. PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LEAV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240871 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE THIRD OF EIGHT REPORTS. REFER TO 2026095-2019-00166 FOR THE FIRST EVENT. REFER TO 2026095-2019-00167 FOR THE SECOND EVENT. REFER TO 2026095-2019-00169 FOR THE FOURTH EVENT. REFER TO 2026095-2019-00170 FOR THE FIFTH EVENT. REFER TO 2026095-2019-00171 FOR THE SIXTH EVENT. REFER TO 2026095-2019-00172 FOR THE SEVENTH EVENT. REFER TO 2026095-2019-00173 FOR THE EIGHTH EVENT. FILL VOLUME: 400 ML . FLOW RATE: 4ML/HR-6ML/HR . PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240868 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT EVENTS. THIS IS THE FIRST OF EIGHT REPORTS. REFER TO 2026095-2019-00167 FOR THE SECOND EVENT. REFER TO 2026095-2019-00168 FOR THE THIRD EVENT. REFER TO 2026095-2019-00169 FOR THE FOURTH EVENT. REFER TO 2026095-2019-00170 FOR THE FIFTH EVENT. REFER TO 2026095-2019-00171 FOR THE SIXTH EVENT. REFER TO 2026095-2019-00172 FOR THE SEVENTH EVENT. REFER TO 2026095-2019-00173 FOR THE EIGHTH EVENT. FILL VOLUME: 400 ML FLOW RATE: 4ML/HR-6ML/HR PROCEDURE: CONTINUOUS PERIPHERAL NERVE BLOCKS FOR SURGICAL PROCEDURES. CATHPLACE: UNKNOWN IT WAS REPORTED THE PUMP WAS RUNNING OUT OF MEDICATION EARLIER THAN EXPECTED. THE DEVICE LASTED ROUGHLY 36-HOURS TO 37-HOURS VERSUS THE 72-HOURS IT SHOULD HAVE LASTED." THERE WAS NO REPORTED PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 14-OCT-2019 STATED, "WE DO EDUCATE THE PATIENTS ON THE PAIN PUMPS AS WELL AS SEND THEM HOME WITH WRITTEN INSTRUCTIONS REGARDING IT. TYPICALLY THE ANESTHESIOLOGIST HAVE THEM LEAVE THE SURGERY CENTER WITH THE PUMP SET AT 4-6ML HOUR. WE INSTRUCT THE PATIENTS TO LEAVE T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240850 ↗
• MalfunctionSep 19, 2019Misconnection; Misconnection

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN . INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5088912 RECEIVED ON 27-AUG-2019, AND THE FOLLOWING INFORMATION WAS PROVIDED: "THE ON-Q PUMP PAIN RELIEF SYSTEM WAS INADVERTENTLY CONNECTED TO THE PT'S HICKMAN CATHETER THAN THE RIGHT CHEST ON-Q CATHETER. WE BELIEVE THIS ERROR WAS DUE IN PART TO THE ABILITY TO EASILY CONNECT THE TWO DEVICES. THE PT'S [PATIENT'S] PAIN CONTROL WAS INITIALLY PROVIDED VIA EPIDURAL CATHETER, HOWEVER, FOLLOWING REMOVAL OF THE EPIDURAL CATHETER, THE PLAN WAS TO BEGIN CONTINUOUS PAIN RELIEF VIA THE ON-Q PAIN RELIEF SYSTEM. THE ON-Q CATHETER WAS PRESENT BUT NOT VISIBLE TO THE NURSE AND HAD NOT BEEN USED UP UNTIL THIS POINT. THE NURSE WAS UNFAMILIAR WITH ON-Q PUMPS AND ASSUMED THE ON-Q PAIN RELIEF SYSTEM SHOULD BE CONNECTED TO THE HICKMAN CATHETER. THE PT RECEIVED ROPIVACAINE VIA THE HICKMAN TIMES FOUR HOURS BEFORE THE ERROR WAS IDENTIFIED AND CORRECTED. THERE WAS NO ADVERSE OUTCOME AS A RESULT OF THIS EVENT. OUR CONCERN WAS THE ABILITY TO EASILY CONNECT THE TWO DEVICES." ADDITIONAL INFORMATION RECEIVED 09-SEP-2019 INDICATED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088190 ↗
• MalfunctionSep 5, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML. FLOW RATE: 6 ML/HR. PROCEDURE: TIBIA/FIBULA FRACTURE/ACHILLES TENDON REPAIR. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE "PUMP [WAS] EMPTY AFTER 2 DAYS OF INFUSION. SAF [SELECT-A-FLOW] SET TO 6 ML/HR. PATIENT STABLE WITH NO S/S [SIGNS/SYMPTOMS] OF LOCAL TOXICITY." "PUMP AT 6 ML/HR FOR THE DURATION OF THE INFUSION ROPIVACAINE 0.2%. PATIENT HAD NO SIDE EFFECTS, NO RINGING IN EARS, NO METAL TASTE IN MOUTH, NO TACHYCARDIA. PATIENT SAYS HE WAS TOLD TO REMOVE THE PUMP ON SUNDAY BUT EARLY ON SATURDAY NOTICED THE PUMP LOOKED EMPTY. PATIENT CONFIRMED IT IS EMPTY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8964398 ↗
• MalfunctionAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 545 ML. FLOW RATE: 8ML/HR. PROCEDURE: LEFT ROTATOR CUFF SURGERY, BICEP RECONNECT . CATHPLACE: UNKNOWN. INFUSION START TIME AND DATE: (B)(6) 2019 AT 4:00PM. INFUSION END TIME AND DATE: (B)(6) 2019 AT 8:00PM. A REPORT WAS RECEIVED VIA THE HOTLINE NURSE, FROM THE PATIENT'S SPOUSE, A LICENSED PRACTICAL NURSE (LPN) STATING THE PATIENT HAD BEEN DOING WELL AND THEN EXPERIENCED SYMPTOMS. IT WAS NOTED THAT 2-DAYS POST PROCEDURE THE PATIENT COMPLAINED OF FACE FEELING NUMB, THE CATHETER INSERTION SITE FELT PAINFUL AND WAS BURNING, AND THE PATIENT'S FACE FELT FLUSHED AND "HOT". THE PATIENT DENIED ANY OTHER SYMPTOMS SUCH NO SHORTNESS OF BREATH (SOB), TINNITUS, METAL TASTE AND NO INCREASE IN PAIN. THE PATIENT WAS ALSO TAKING PERCOCET AND IBUPROFEN FOR PAIN. THE DEVICE WAS INFUSING AT A RATE OF 8ML/HR SINCE SURGERY AND HAD NOT BEEN ADJUSTED. THE PUMP WAS SHRINKING AND ABOUT SIZE OF LEMON. THE HOTLINE NURSE EDUCATED THE PATIENT TO CLAMP THE PUMP AND CALL ANESTHESIA TO INFORM OF THEM OF THE SYMPTOMS. THE PATIENT'S SPOUSE CALLED BACK, 20-MINUTES AFTER THE FIRST CALL WAS PLACED TO HOTLINE NURSE, AND SHE REPORTED THE PATIENT HAD NICKEL SIZE REDNESS AND SWELLING AT THE INSERTION SITE. SHE

  Patient problems: No Code Available; Numbness; Pain

  MAUDE report 8871713 ↗
• MalfunctionJul 12, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500 ML; FLOW RATE: 8 ML/HR; PROCEDURE: KNEE SURGERY; CATHPLACE: ADDUCTOR CANAL BLOCK; INFUSION START TIME: (B)(6) 2019 1000; INFUSION STOP TIME: (B)(6) 2019 0700. IT WAS REPORTED THAT THE "PUMP WAS PLACED ON MONDAY [(B)(6) 2019] AT 10 AM AND FILLED WITH 500 OF 0.2%ROPI [ROPIVACAINE]. PATIENT WENT TO THE ED [EMERGENCY DEPARTMENT] ON WEDNESDAY [(B)(6) 2019] AT 0700 AND THE PUMP WAS EMPTY. 16 HOURS EARLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8785461 ↗
• MalfunctionJun 21, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ADDITIONAL INFORMATION RECEIVED 23-AUG-2019 INDICATED "JUST SPOKE TO [PHYSICIAN]. THE PUMP RAN DRY AFTER 16-17 HOURS. SET AT 8CC PER HOUR. PATIENT NEVER CAME BACK FOR POST OP APPOINTMENT AND THEY HAVE BEEN UNABLE TO GET THE PUMP."

  Patient problems: Pain

  MAUDE report 8725006 ↗
• MalfunctionJun 13, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT "AN OUTPATIENT HAD A FAST FLOW ISSUE." MEDICATION WAS "DUMPED IN FOUR HOURS." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8697983 ↗
• MalfunctionMay 15, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500 ML, FLOW RATE: 8 ML/HR, PROCEDURE: CPNB [CONTINUOUS PERIPHERAL NERVE BLOCK], CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED "PUMP POSSIBLY DELIVERED MEDICATION AT A QUICK FLOW RATE. SHOULD HAVE LASTED ABOUT 3 DAYS AND WAS EMPTY IN ABOUT 1.5 DAYS WHILE PATIENT WAS IN THE HOSPITAL." NO PATIENT INJURY REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612892 ↗
• MalfunctionApr 26, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN, FLOW RATE: 6ML/HR, PROCEDURE: SHOULDER SURGERY, CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. ADDITIONAL INFORMATION RECEIVED 09-APR-2019 STATED THE PATIENT REPORTED A "DENSE" FEELING IN HER ARM AT THAT TIME. THE PATIENT STATED THE DEVICE RAN OUT AFTER 60-HOURS, NOT TOO FAST, BUT FASTER THAN EXPECTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558075 ↗
• MalfunctionApr 24, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2019-00065 FOR THE SECOND EVENT. REFER TO 2026095-2019-00066 FOR THE THIRD EVENT. FILL VOLUME: 550 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, IT WAS REPORTED THE ONQ PUMPS WERE RUNNING OUT TOO QUICKLY. THE PUMPS WERE COMPLETELY INFUSING ON POST-OPERATIVE DAY (POD) THREE INSTEAD OF ON POD FOUR. ADDITIONAL INFORMATION RECEIVED 29-MAR-2019 STATED THE ONQ PUMPS APPEARED TO BE RUNNING OUT EARLIER THAN EXPECTED GIVEN THE SET RATE, ONLY LASTING UNTIL POD#3 AT RATE OF 6 ML/HR ON 550ML FILL AND SHOULD HAVE LASTED UNTIL POD#4. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547602 ↗
• MalfunctionApr 24, 2019Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2019-00064 FOR THE FIRST EVENT. REFER TO 2026095-2019-00065 FOR THE SECOND EVENT. FILL VOLUME: 550 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE ONQ PUMPS WERE RUNNING OUT TOO QUICKLY. THE PUMPS WERE COMPLETELY INFUSING ON POST-OPERATIVE DAY (POD) THREE INSTEAD OF ON POD FOUR. ADDITIONAL INFORMATION RECEIVED 29-MAR-2019 STATED THE ONQ PUMPS APPEARED TO BE RUNNING OUT EARLIER THAN EXPECTED GIVEN THE SET RATE, ONLY LASTING UNTIL POD#3 AT RATE OF 6 ML/HR ON 550ML FILL AND SHOULD HAVE LASTED UNTIL POD#4. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547596 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

• Z-2860-2011 · Apr 15, 2011 · Terminated
  I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
• Z-2133-2008 · Feb 14, 2008 · Terminated
  On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
• Z-1869-2008 · Feb 12, 2008 · Terminated
  ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest