ON-Q* Pain Relief System with SELECT-A-FLOW 13472Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00193494134723), received between Aug 13, 2020 and Mar 18, 2025 — classified as 7 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (52 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 550ML .2% ROPIVACAINE ML. FLOW RATE: 6ML PER HOUR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN PERINEURAL. INFUSION START TIME: ON (B)(6) 2025. INFUSION STOP TIME: ON (B)(6) 2025 AT 4AM. IT WAS REPORTED, THEY PLACED AN ON-Q PUMP ON FRIDAY, AND IT RAN DRY BY 4AM ON SUNDAY MORNING. NO REPORT OF ADVERSE EFFECT TO PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 13MAR2025, ¿CHANGED TO NEW ON Q. NO NERVE ISSUE.¿ NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634240 ↗
• MalfunctionSep 25, 2024Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 360 ML. FLOW RATE: 6 ML/HR. PROCEDURE: PERIPHERAL NERVE BLOCK. CATHPLACE: LEFT FASCIA ILIACA BLOCK. INFUSION START TIME: (B)(6) 2024 1202. INFUSION STOP TIME: (B)(6) 2024 1600. IT WAS REPORTED, ¿PEDIATRIC PATIENT WHOSE PAIN PUMP RAN OUT EIGHT HOURS BEFORE IT WAS SUPPOSED TO. THE RATE HAD BEEN SET AND LOCKED AND THE PUMP WAS DELIVERING A HIGHER RATE SINCE IT RAN OUT TOO QUICKLY.¿ PER ADDITIONAL INFORMATION RECEIVED ON 16SEP2024, THE INCIDENT ¿RESULTED IN INCREASED PAIN WHICH HAD TO BE MANAGED BY INCREASING NARCOTIC AND NON-NARCOTIC MEDICATIONS WHILE PATIENT WAS AT HOME. PATIENT¿S MOTHER CALLED THE HOSPITAL AND SPOKE TO THE REGISTERED NURSE (RN) REGARDING THE SITUATION. MEDICAL DOCTOR (MD) WAS CALLED FOR PAIN MEDICATIONS TO HELP WITH INCREASED PAIN PATIENT WAS THEN EXPERIENCING.¿ ORAL MEDICATIONS PRESCRIBED WERE OXYCODONE, GABAPENTIN, TYLENOL, AND IBUPROFEN.

  Patient problems: Insufficient Information

  MAUDE report 20305461 ↗
• InjuryAug 14, 2024Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem; Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 8-12CC/HR . PROCEDURE: RIGHT TOTAL KNEE ARTHROPLASTY (TKA). CATHPLACE: UNKNOWN . INFUSION START TIME: 02JUL2024. INFUSION STOP TIME: 04JUL2024. IT WAS REPORTED, SURGEON NOTIFIED THAT PATIENT WAS READMITTED TO HOSPITAL. PATIENT¿S CONTINUOUS ON-Q PUMP WAS DISCONTINUED, AND SEVERAL TESTS COMPLETED. SURGEON HAS DOCUMENTED THE PUMP WAS WORKING AS IT SHOULD. PER ADDITIONAL INFORMATION RECEIVED ON 22JUL2024, PATIENT HAD RIGHT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2024 AS AN OUTPATIENT. PATIENT COMMUNICATED WITH TEAM ON (B)(6)2024, DID OUTPATIENT PHYSICAL THERAPY ON (B)(6) 2024, AND WENT TO BED UNEVENTFULLY. PATIENT WAS FOUND UNRESPONSIVE ON (B)(6) 2024 AT 2PM. PATIENT WAS TAKEN BY EMS TO REGIONAL HOSPITAL WHERE SHE WAS INTUBATED, FOUND TO BE IN RENAL AND HEPATIC FAILURE. PATIENT WAS IN ICU WITH INTUBATION FOR 4 DAYS. PATIENT IMPROVED ON SUPPORTIVE CARE AND ORGAN SYSTEMS NORMALIZED. COGNITIVELY IMPROVING BACK TO BASELINE AS LAST VISIT. TRANSFERRED TO NURSING HOME FOR REHABILITATION. ICU TEAM TREATED AS LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST) PRESUMPTIVELY BUT ETIOLOGY UNCERTAIN. PICTURES OF PUMP WAS TAKEN SHOWING SOME FLUID REMAINING IN THE PUMP. IT WAS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Decreased Level of Consciousness; Liver Failure; Renal Failure

  MAUDE report 19983332 ↗
• MalfunctionJun 5, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED VIA FDA USER FACILITY REPORT MW REPORT (B)(4) AND THE FOLLOWING INFORMATION WAS PROVIDED: "BUPIVACAINE ONQ PUMP CB004 SET UP AND INITIATED AT APPROXIMATELY 14:00 TO INFUSE AT 10ML/HR FOR 55 HOURS AND END AT 23:00 2 DAYS LATER. UPON SPEAKING TO PATIENT, THE PUMP EMPTIED EARLY IN THE MORNING ESTIMATED AT 01:00. NO SIDE EFFECTS OR SYMPTOMS OF LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST). NURSE MANAGER INFORMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468212 ↗
• MalfunctionNov 2, 2023Leak/Splash; Improper Flow or Infusion; Material Split, Cut or Torn; Leak/Splash; Improper Flow or Infusion; Material Split, Cut or Torn

  FILL VOLUME: 545 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18060772 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 550 ML, FLOW RATE: UNKNOWN, PROCEDURE: TOTAL KNEE ARTHROPLASTY, CATHPLACE: ADDUCTOR CANAL, INFUSION START TIME: ON (B)(6) 2023, INFUSION STOP TIME: ON (B)(6) 2023. IT WAS REPORTED, PATIENT RECEIVED AN ADDUCTOR CANAL CATHETER PRE-OPERATIVELY FOR POST-OPERATIVE PAIN CONTROL FOLLOWING TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023. PATIENT DISCHARGED HOME ON (B)(6) 2023 WITH ON-Q PUMP AND ADDUCTOR CANAL CATHETER IN PLACE. WHEN THE PATIENT ARRIVED HOME, THE PATIENT COMPLAINED OF RINGING IN THE EARS, METALLIC TASTE IN THE MOUTH, AND FEELING LIGHTHEADED. THE PUMP AND CATHETER WERE REMOVED, AND THE SYMPTOMS RESOLVED. NO INJURY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dizziness; Tinnitus

  MAUDE report 17324402 ↗
• InjuryApr 3, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: SHOULDER SURGERY. CATHPLACE: UNKNOWN. IT WAS REPORTED "WHEN THE CATHETER WAS PLACED, I EXPRESSED CONCERN THAT I STILL FELT SENSATIONS IN MY LEFT FOURTH AND FIFTH FINGER AND NOT COMPLETE NUMBNESS IN THE HAND. I EXPERIENCED QUITE A BIT OF PAIN POST-OP AND THE BALL WAS COMPLETELY EMPTY AFTER TWO DAYS. FOR THE LAST TWO DAYS, I HAVE BEEN HAVING SEVERE MUSCLE CRAMPS IN MY BACK AND ARM IN THE SURGERY AREA. IT SEEMS AS IF THE PAIN MEDICATION LEAKED OUT TOO QUICKLY." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED AND THE USER STATES "THAT HE IS VERY SUSPICIOUS ABOUT THE ANESTHESIOLOGIST'S TECHNIQUE OF INSERTING THE CATHETER (SHE'S NEW, AND IT TOOK HER A LONG TIME; AFTER I TOLD HER IT DIDN'T FEEL RIGHT, SHE TOLD ME THEY WOULD WORRY ABOUT THAT LATER.' PATIENT STATES "IT IS NOT YOUR PRODUCT, OK? I REALLY THINK THEY MESSED UP WHERE THEY PUT IT." AT THE TIME OF CALL PATIENT'S SYMPTOMS WERE NOT PRESENT. DENIES ANYTHING FURTHER THAN WHAT WAS ORIGINALLY REPORTED. ASKED PATIENT IF HE CONTACTED THE PHYSICIAN, HE SAID "HECK NO, THEY DON'T CARE." ADVISED HIM TO CONTACT THE PHYSICIANS AND ANESTHESIA TO NOTIFY THEM OF THE ISSUE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Numbness; Pain

  MAUDE report 16666717 ↗
• InjuryFeb 24, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 545 ML. FLOW RATE: 8ML/HR. PROCEDURE: ROTATOR CUFF. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2023, 5PM. INFUSION STOP TIME: (B)(6) 2023, 10:03 AM. IT WAS REPORTED THAT THE PATIENT BELIEVED THE PUMP EMPTIED ¿A COUPLE¿ HOURS EARLY, BASED ON THE DIAL SETTING, 8ML/HR. NO SYMPTOMS OF TOXICITY REPORTED, HOWEVER THEY DID COMPLAIN OF EXTREME NUMBNESS DOWN THE OPERATIVE ARM INTO THE THUMB, MIDDLE AND INDEX FINGERS. IT WAS ADDITIONALLY REPORTED THAT THROUGHOUT THE NIGHT, THE PUMP WAS LOCATED AT THEIR WAIST UNDER THE BLANKET AND WAS COMPLETELY EMPTY WHEN THEY WOKE UP. THEY STATED THEY WERE NOT EDUCATED ON THE PUMP PRIOR TO DISCHARGE FROM THE FACILITY AND WERE UNAWARE THE PUMP FLOW RATE COULD BE AFFECTED BY THE TEMPERATURE THE PUMP WAS EXPOSED TO. THE NUMBNESS RESOLVED, AND NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Numbness

  MAUDE report 16439958 ↗
• MalfunctionJan 25, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550ML. FLOW RATE: 10ML/HR. PROCEDURE: REVISION OF LEFT ULNAR JOINT PROCEDURE. CATHPLACE: UNKNOWN. AN FDA USER FACILITY REPORT#: MW 400100000-2022-8130 RECEIVED, AND THE FOLLOWING INFORMATION WAS PROVIDED: ONQ BUPIVACAINE 0.2% AT 10ML/HR DUE TO BE EMPTY AT 1830. PATIENT REPORTS ONQ EMPTY AT 0800. RATE REGULATOR SET AT 10ML/HR CHECKED BY PATIENT. INFUSION POSSIBLY RAN IN AT A FASTER RATE ENDING SOONER THAN ANTICIPATED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16243873 ↗
• InjuryJan 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED, THE PATIENT EXPERIENCED BALANCE ISSUES; THE EXPECTED RUN TIME [ON THE PUMP] WAS 55 HOURS.

  Patient problems: Balance Problems; Dizziness; Nausea

  MAUDE report 16224804 ↗
• MalfunctionJan 6, 2023Pumping Problem

  EVENT1: ON-Q PUMP RAN OUT IN 30 HOURS INSTEAD OF EXPECTED 55 HOURS. PUMP HAS BEEN RETURNED AND IS CURRENTLY UNDER EVALUATION. DIAL WAS SET AT APPROPRIATE PRESCRIBED RATE OF 10 ML/HR. CLAMP WAS OPEN AND ALL APPEARED TO BE VISIBLY INTACT, AS WOULD BE EXPECTED. PATIENT REPORTED NAUSEA AND BALANCE ISSUES, WHICH IS THOUGHT TO BE LIKELY A SIDE EFFECT OF THE FASTER INFUSION. EVENT2: PATIENT'S ON-Q PUMP WAS STILL HALF FULL WHEN IT WAS TIME TO BE REMOVED. RATE DIAL SET AT PROGRAMMED RATE. INFUSION CLAMP WAS OPEN. PATIENT INSTRUCTED TO BRING CATHETER AND ON-Q PUMP WITH HIM FOR RETURN VISIT. EVENT3: I HAVE A PATIENT THAT WENT HOME YESTERDAY WITH AN ON-Q AND THE PUMP IS NOT INFUSING. THE PUMP HAS BEEN CONNECTED FOR 24 HOURS AND THE PATIENT SAYS IT HAS NOT DECREASED IN SIZE AT ALL. RATE DIAL VERIFIED. PATIENT INSTRUCTED TO BRING PUMP BACK FOR RETURN VISIT.

  Patient problems: Balance Problems; Nausea

  MAUDE report 16111323 ↗
• MalfunctionDec 29, 2022Excess Flow or Over-Infusion; Application Program Problem: Medication Error

  ONQ BUPIVACAINE 0.2% AT 10ML/HR DUE TO BE EMPTY AT 1830. PATIENT REPORTS ONQ EMPTY AT 0800. RATE REGULATOR SET AT 10ML/HR CHECKED BY PATIENT. INFUSION POSSIBLY RAN IN AT A FASTER RATE ENDING SOONER THAN ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067800 ↗
• MalfunctionDec 20, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550 ML, FLOW RATE: 8 ML/HR , PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: (B)(6) 2022, INFUSION STOP TIME: (B)(6) 2022. THE PATIENT REPORTED, THE PUMP WAS EMPTY ON (B)(6) 2022; IT EMPTIED IN 26HRS INSTEAD OF 72HRS, THE DIAL WAS ON ¿8¿. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015577 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 2026095-2022-00136 FOR THE FIRST EVENT. FILL VOLUME: 545 ML FLOW RATE: 8 ML/HR. PROCEDURE: ACL RECONSTRUCTION/MENISCUS REPAIR/ORTHOSCOPY RIGHT KNEE. WITH ACL RECONSTRUCTION WITH QUADRICEPS PATELLA AUTOGRAFT AND MENISCUS REPAIR. START DATE AND TIME OF PROCEDURE: (B)(6) 2022 AT 1000 CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT HAD A PUMP THAT WAS INFUSING AT A RATE OF 8 ML/HR OF 0.2% ROPIVACAINE AND EXPERIENCED SYMPTOMS. THE PATIENT EXPERIENCED "METAL TASTE AND TONGUE NUMBNESS. CLAMPING THE INFUSION RESOLVED THE PROBLEM." THE CATHETER WAS REMOVED. ALL SYMPTOMS SUBSIDED. ADDITIONAL DETAILED INFORMATION NOTES HEALTHCARE PROVIDER INSTRUCTED CAREGIVER TO CLAMP BALL AND CALL BACK IN ONE HOUR. THE CAREGIVER THEN CALLED BACK AROUND 11PM AND REPORTED RESOLUTION OF METALLIC TASTE BUT CONTINUES TONGUE NUMBNESS. DUE TO CONCERNS FOR TOXICITY DECISION WAS MADE TO REMOVE CATHETER. THE CATHETER WAS REMOVED VIA TELEPHONE PHONE INSTRUCTIONS WITH CAREGIVER AND THE CATHETER VERIFIED TIP WAS INTACT. THE

  Patient problems: Numbness; Taste Disorder

  MAUDE report 15954983 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 2026095-2022-00137 FOR THE SECOND EVENT. FILL VOLUME: 545 ML. FLOW RATE: 8 ML/HR. PROCEDURE: RIGHT ACL FEMORAL CATHETER/ORTHOSCOPY RIGHT KNEE. WITH ACL RECONSTRUCTION WITH QUADRICEPS PATELLA AUTOGRAFT. AND POSSIBLE MENISECTOMY OR MENISCUS REPAIR. START DATE AND TIME OF PROCEDURE: ON (B)(6) 2022 AT 1000. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT HAD A PUMP THAT WAS INFUSING AT A RATE OF 8 ML/HR OF 0.2% ROPIVACAINE AND EXPERIENCED SYMPTOMS. THE PATIENT EXPERIENCED "METAL TASTE AND TONGUE NUMBNESS. CLAMPING THE INFUSION RESOLVED THE PROBLEM." ALL SYMPTOMS SUBSIDED. DETAILED INFORMATION FROM HEALTH CARE PROVIDER NOTED ASKED CAREGIVER TO CLAMP THE ON-Q PUMP OFF AND ONE HOUR LATER FOLLOWED-UP AND NOTED THE METALLIC HAD RESOLVED BUT THE NUMBNESS CONTINUED. THE DECISION WAS MADE TO REMOVE CATHETER AND CONTINUE ORAL MEDICATIONS. THE CATHETER WAS REMOVED WHILE THE CAREGIVER WAS ON THE PHONE AND THE CATHETER TIP WAS VERIFIED TO BE INTACT. THEN ON 12-NOV-2022 AT 1151 A FOLLOW-UP PHONE CALL F

  Patient problems: Numbness; Taste Disorder

  MAUDE report 15951489 ↗
• MalfunctionNov 7, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550 ML. FLOW RATE: 6 ML/HR. PROCEDURE: HAND PROCEDURE SUPRACLAVICULAR. BLOCK PERFORMED. CATHPLACE: UNKNOWN. DATE AND TIME OF THE START: 12PM ON (B)(6) 2021. DATE AND TIME OF FINISH: ON THE MORNING OF (B)(6) 2021. THE PUMP WAS CLAMPED AND REMOVED. IT WAS REPORTED THE PATIENT "INDICATED THAT THE MEDICATION RAN OUT MUCH TOO QUICKLY DURING HER TREATMENT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 22-OCT-2021 STATED THE PATIENT EXPERIENCED "NAUSEA". SURGEON SAW PATIENT RECENTLY FOR A POST-OPERATIVE VISIT AND THE PATIENT IS CURRENTLY "DOING FINE". NO OTHER DETAILS PROVIDED.

  Patient problems: Nausea

  MAUDE report 12759264 ↗
• MalfunctionOct 21, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550 ML. FLOW RATE: 10 ML/HR. PROCEDURE: LEFT KNEE TOTAL REPLACEMENT. CATHPLACE: LEFT KNEE REGIONAL BLOCK. DATE OF PROCEDURE: (B)(6) 2021. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP WAS EXPERIENCING A FAST FLOW ISSUE AFTER A TOTAL KNEE PROCEDURE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS, NUMBNESS, AND TINGLING AS A RESULT OF THE PUMP INFUSING TOO QUICKLY. ADDITIONAL INFORMATION RECEIVED 29-SEP-2021 STATED DOING WELL AND SIDE EFFECTS SUBSIDED.

  Patient problems: Fatigue; Numbness

  MAUDE report 12678201 ↗
• MalfunctionAug 24, 2021Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 500 ML. FLOW RATE: 8 ML/HR. PROCEDURE: "ACHILLES PROCEDURE." CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2021 0920. INFUSION STOP TIME: (B)(6) 2021 0400. IT WAS REPORTED THAT "FAST FLOW" EVENT OCCURRED. THE PATIENT CALLED AND STATED THE PUMP WAS "PUT IN AT 0745 AFTER ACHILLES PROCEDURE ON FRIDAY (B)(6) [(B)(6) 2021] THAT WAS RUNNING AT 8 ML/HR THE ENTIRE TIME RAN OUT ON SUNDAY MORNING AT ABOUT 0400." PUMP INFUSED IN LESS THAN 2 FULL DAYS. NO SIDE EFFECTS REPORTED, BUT PATIENT WAS IN PAIN AND WAS TOLD THE PUMP WOULD RUN OUT ON MONDAY. ADDITIONAL INFORMATION RECEIVED 03-AUG-2021 INDICATED THE INFUSION WAS STARTED (B)(6) 2021 AT 0920. THE PRODUCT WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS AND FACILITY CONDITIONS DID NOT CONTRIBUTE TO THIS EVENT. THE FACILITY IS NOT A NEW OR INEXPERIENCED USER.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12361422 ↗
• MalfunctionJul 1, 2021Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 550ML

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12101806 ↗
• MalfunctionMay 6, 2021Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 100 ML, FLOW RATE: 2 ML/HR, PROCEDURE: TOTAL KNEE REPLACEMENT, CATHPLACE: SURGICAL WOUND SITE, INFUSION START TIME: (B)(6) 2021 AT 1230, INFUSION STOP TIME: (B)(6) 2021 AT 2130. IT WAS REPORTED THAT THE PUMP EMPTIED OVERNIGHT. IT WAS ONLY SUPPOSED TO RUN AT 2ML/HR AND AT THE POINT THE OVER-INFUSION WAS NOTED, ONLY 40ML SHOULD HAVE BEEN INFUSED, HOWEVER, 90ML HAD INFUSED. THE PUMP WAS FILLED WITH 100ML OF A LOCAL ANESTHETIC, WHICH IS LESS THAN LABELED VOLUME. ADDITIONAL INFORMATION RECEIVED 19-APR-2021 INDICATED THE "SCRUB NURSE ARRIVED IN THEATRE AND PACKAGE OF ON Q PUMP OPENED AND DISCARDED AND NOT SEEN BY NURSE WHO FILLED THE PUMP. SCRUB AND SCOUT NURSE UNFAMILIAR WITH THE PUMP. THE PAIN PUMP USUALLY USED BY THIS SURGEON WAS UNAVAILABLE. THE [ANESTHETIST] WAS ASKED IF THE PUMP COULD BE FILLED WITH 100ML 0.75% NAROPIN AND THE TEAM WERE GIVEN THE GO AHEAD. THE PAIN PUMP WAS SET TO 2 ML PER HOUR DELIVERY AND ATTACHED TO THE PATIENT...THE PAIN PUMP WAS FOUND ON THE WARD EMPTY ON THE NIGHT DUTY. INCREASED SURVEILLANCE OF THE PATIENT. PATIENT DEVELOPED NO SIGN OF LOCAL ANESTHETIC TOXICITY." PATIENT'S CURRENT STATUS WAS LISTED AS "OK, NO ADVERSE EVENTS REPORTED. NIL ADVERSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787596 ↗
• MalfunctionJan 21, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400ML. FLOW RATE: UNKNOWN. PROCEDURE: A ROBOTIC GYN SURGERY. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. MEDICATION: ROPIVACAINE. IT WAS REPORTED THAT DURING A FOLLOW UP APPOINTMENT THE PATIENT REPORTED TO THE PHYSICIAN THAT THE PUMP HAD EMPTIED IN ONE DAY. THERE WAS NO OBVIOUS DEFECTS TO THE PUMP, AND NO INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. THE PRACTICE REPORTED THAT THEY HAVE USED THE PUMPS FOR 10 YEARS, SO THEY ARE FAMILIAR WITH ITS USE AND FACTORS WHICH AFFECT FLOW RATE. THE PATIENTS ARE EDUCATED ON THE PUMP AT THE PRE-OP APPOINTMENT AND ON THE DAY OF SURGERY. THEY ARE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210733 ↗
• MalfunctionJan 19, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 440ML. FLOW RATE: 6ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED VIA MW5098163 RECEIVED FROM FDA THAT THE PUMP WAS EMPTIED OF ROPIVACAINE 0.2% AFTER 16 HOURS INSTEAD OF THE INTENDED 55-72 HOUR DURATION. THIS RESULTED IN SEVERAL HOURS OF NO PAIN RELIEF FOR THE PATIENT. NO PATIENT INJURY REPORTED. THE PATIENT HAD BEEN DISCHARGED, SO PLACEMENT OF A NEW PUMP WAS NOT POSSIBLE. PER INFORMATION PROVIDED BY THE HOSPITAL SAFETY OFFICER, THE PATIENT RECEIVED POST PROCEDURE PAIN RELIEF WITH ORAL MEDICATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11197359 ↗
• MalfunctionDec 18, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED ON 05-JAN-2021 VIA FDA MEDWATCH/ FDA USER FACILITY REPORT # MW5098164 AND THE FOLLOWING WAS NOTED: A 50 PATIENTS, OCTOBER-NOVEMBER, UTILIZING THE ON Q ELASTOMERIC PUMP 400ML WITH ROPIVICAINE 0.2%, HAD PUMP EMPTY PRIOR TO INTENDED INFUSION DURATION RESULTING IN SEVERAL HOURS OF NO PAIN RELIEF AS PROMISED, MOST PATIENTS WERE DISCHARGED AND SO COULDN'T PROVIDE ANOTHER PUMP. ANTICIPATED INFUSION TIME RANGED FROM 55-110 HOURS, BUT RESULTING INFUSION TIME WAS 34-72 HOURS. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11042241 ↗
• MalfunctionDec 13, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED ON 05-JAN-2021 VIA FDA MEDWATCH/ FDA USER FACILITY REPORT # MW5098164 AND THE FOLLOWING WAS NOTED: A 50 PATIENTS, (B)(6), UTILIZING THE ON Q ELASTOMERIC PUMP 400ML WITH ROPIVICAINE 0.2%, HAD PUMP EMPTY PRIOR TO INTENDED INFUSION DURATION RESULTING IN SEVERAL HOURS OF NO PAIN RELIEF AS PROMISED, MOST PATIENTS WERE DISCHARGED AND SO COULDN'T PROVIDE ANOTHER PUMP. ANTICIPATED INFUSION TIME RANGED FROM 55-110 HOURS, BUT RESULTING INFUSION TIME WAS 34-72 HOURS. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10998428 ↗
• MalfunctionDec 13, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIFTY DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIFTY DIFFERENT EVENTS. THIS IS THE FORTY EIGHTH OF FIFTY REPORTS. REFER TO 2026095-2020-00129 FOR THE FIRST EVENT. REFER TO 2026095-2020-00130 FOR THE SECOND EVENT. REFER TO 2026095-2020-00131 FOR THE THIRD EVENT. REFER TO 2026095-2020-00132 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00133 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00134 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00135 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00136 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00137 FOR THE NINTH EVENT. REFER TO 2026095-2020-00138 FOR THE TENTH EVENT. REFER TO 2026095-2020-00139 FOR THE ELEVENTH EVENT. REFER TO 2026095-2020-00140 FOR THE TWELFTH EVENT. REFER TO 2026095-2020-00141 FOR THE THIRTEENTH EVENT. REFER TO 2026095-2020-00142 FOR THE FOURTEENTH EVENT. REFER TO 2026095-2020-00143 FOR THE FIFTEENTH EVENT. REFER TO 2026095-2020-00144 FOR THE SIXTEENTH EVENT. REFER TO 2026095-2020-00145 FOR THE SEVENTEENTH EVENT. REFER TO 2026095-2020-00146 FOR THE EIGHTEENTH EVENT. REFER TO 2026095-2020-00147 FOR THE NINETEENTH EVENT. REFER TO 202609

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10998422 ↗

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