Halyard 13476Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10680651134766), received between Jan 6, 2017 and Jun 25, 2019 — classified as 1 death, 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: 2 ML/HR, PROCEDURE: FASCIA ILIACA BLOCK, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A PATIENT "WENT TO THE ER [EMERGENCY ROOM] WITH NUMBNESS IN THE MOUTH, PAINS IN THE CHEST, AND A SEIZURE." THE PUMP WAS "INSTALLED ON MONDAY, ER DOC [DOCTOR] SAID THE PUMP WAS EMPTY. ANESTHESIOLOGIST SAID HE SET FLOW RATE AT 2ML/HR, OK¿D PATIENT TO ADJUST TO 14 IMMEDIATELY FOLLOWING PT [PHYSICAL THERAPY] THEN HE WOULD TURN IT BACK DOWN". ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN ON 12-JUN-2019 INDICATED THE PATIENT IS IN STABLE CONDITION. "PATIENT PRESENTED TO ER WITH ORAL NUMBNESS, CHEST PAIN, ABDOMINAL PAIN, AND A TRIPLE AAA [ABDOMINAL AORTIC ANEURYSM]. STATES MEDICATION WAS BUPIVACAINE AND THE PATIENT WAS A KNOWN OPIOID ABUSER, AND WAS EXPERIENCING RELIEF UNTIL THE SYMPTOMS HE EXPERIENCED WHEN HE PRESENTED AT ER." "STATES PATIENT WAS TREATED SUCCESSFULLY WITH LIPIDS. STATES HE STARTED PATIENT ON 2 CC/HR AND TOLD THE PATIENT HE COULD TURN UP TO 14 CC/HR WHEN DOING PT, AND WHEN DONE PT COULD TURN BACK DOWN. PHYSICIAN STATES WHEN PATIENT PRESENTED TO ER, PATIENT TOLD THEM HE HAD THE PUMP AT 2 CC/HR. PH

  Patient problems: Abdominal Pain; Aneurysm; Chest Pain; Numbness; Seizures

  MAUDE report 8730332 ↗
• MalfunctionMay 21, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML, FLOW RATE: 10 ML/HR, PROCEDURE: SHOULDER ARTHROSCOPY, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT "THE PATIENT'S PUMP EMPTIED TOO QUICKLY, ABOUT 28HRS AFTER START OF THERAPY". THE TOTAL FILL VOLUME THAT PHARMACY PUT ON THE LABEL WAS 400ML. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY SIDE EFFECTS OF LOCAL TOXICITY. PUMP WAS UNDERFILLED 400 ML IN A 600 ML PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8628397 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 750 ML, FLOW RATE: 8 ML/HR, PROCEDURE: HYSTERECTOMY, CATHPLACE: ABDOMEN. IT WAS REPORTED THAT A PATIENT EXPERIENCED A SEIZURE DURING THE USE OF AN ON-Q PUMP AFTER HER SURGERY. THE PATIENT HAD A HYSTERECTOMY ON (B)(6) 2018 AND WAS CONNECTED TO AN ON-Q PUMP RIGHT AFTER THE SURGERY. THE PATIENT EXPERIENCED A GRAN MAL SEIZURE THE SAME NIGHT THAT LASTED A FEW SECONDS. THE NURSE STATED THAT THE PATIENT HAS A SEIZURE HISTORY SO THE PUMP WAS DISCONNECTED RIGHT AWAY JUST IN CASE. HOWEVER, THE PHYSICIAN DID NOT BELIEVE THE SEIZURE WAS RELATED TO THE LOCAL ANESTHETIC FROM THE PUMP. THE PATIENT RECEIVED DILANTIN TREATMENT AND IS DOING OKAY.

  Patient problems: Seizures, Grand-Mal

  MAUDE report 8185512 ↗
• DeathOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 750 ML. FLOW RATE: 14 ML/HR. PROCEDURE: RIB FRACTURES. CATHPLACE: SUBPLEURAL NERVE BLOCK. IT WAS REPORTED THAT A PATIENT DIED ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. THE PATIENT WAS AN (B)(6) FEMALE PATIENT THAT HAD NINE RIB FRACTURES AFTER BEING INVOLVED IN A CAR ACCIDENT. SURGERY WAS PERFORMED ON THE PATIENT ON (B)(6) 2018. A CATHETER WAS PLACED ON THE SUBPLEURAL NERVE BLOCK FOR USE WITH AN ON-Q PUMP FOLLOWING THE SURGERY. THE PATIENT WAS REPORTED TO BE DOING WELL POST-OP. ON (B)(6) 2018 IT WAS NOTED THAT THE PATIENT'S OXYGEN LEVEL DESATURATED RAPIDLY AND WENT INTO PEA (PULSELESS ELECTRICAL ACTIVITY). THE PATIENT DIED WITH AN UNKNOWN CAUSE OF DEATH. NO DRUG LEVEL IN THE BLOOD WAS ASSESSED AND NO AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 7986304 ↗
• MalfunctionSep 10, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 750 ML, FLOW RATE: 8ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE EMPTIED EARLIER THAN EXPECTED. THE PUMP EMPTIED PRIOR TO 48-HOURS AND WAS NEVER INCREASED ABOVE RATE OF 8ML/HR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7860793 ↗
• MalfunctionJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 750 ML, FLOW RATE: 8 ML/HR, PROCEDURE: ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY AND UROLOGICAL PROCEDURE, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT EXPERIENCED A REACTION ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. THE PATIENT HAD A ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY AND UROLOGICAL PROCEDURE, AND WAS TO RECEIVE DISCHARGE INSTRUCTIONS AFTER THE SURGERY BUT DID NOT DUE TO THE LATENESS OF THE PROCEDURE. THE NEXT DAY, THE PATIENT WAS VERY NAUSEOUS AND WAS VOMITING, ASSOCIATED WITH THE ANESTHESIA. THE PATIENT WAS GIVEN ZOFRAN AND PHENERGAN, AND NOTED THAT THE PHENERGAN HELPED A LITTLE, BUT STILL THE PATIENT APPEARED PALE AND FLUSHED. IT WAS SUGGESTED TO CLAMP THE ON-Q PUMP FOR 4-5 HOURS TO SEE IT THAT WOULD HELP. A COUPLE OF HOURS LATER, THE PATIENT BEGAN TO FEEL BETTER AND THE CATHETER WAS REMOVED AT 9 PM. THE NEXT MORNING, THE PATIENT HAD A RASH, BUT FURTHER DETAILS WERE NOT SPECIFIED. IT WAS NOTED THAT THE PATIENT COULD BE ALLERGIC TO THE ROPIVACAINE.

  Patient problems: Nausea; Vomiting

  MAUDE report 7679227 ↗
• MalfunctionJun 28, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500 ML, FLOW RATE: 6 ML/HR, PROCEDURE: HYSTERECTOMY, CATHPLACE: UNDER UMBILICUS, INFUSION START TIME: 1136 ON (B)(6) 2018, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A PATIENT INITIALLY CALLED TO INQUIRE ON HOW TO TELL IF THE ELASTOMERIC PUMP WAS EMPTY. THE PATIENT STATED THAT THE PAIN WAS MINIMAL, AND NONEXISTENT AT THE TIME OF THE REPORT. THE PUMP WAS SET TO A RATE OF 6 ML/HR SINCE THE SURGERY AND WAS ADVISED NOT TO CHANGE THE RATE. THE DRESSING AT THE INSERTION SITE, BELOW THE BELLY BUTTON, WAS DRY AND INTACT. THE CATHETER WAS ALSO INTACT WITH NO KINKS. THE PATIENT STATED SHE COULD NOT RECALL WHAT THE PUMP LOOKED LIKE ORIGINALLY, BUT NOTED THAT IT WAS SMALLER IN SIZE COMPARABLE TO A TANGERINE. THEN THE PATIENT NOTED THAT THE PUMP WAS EMPTY. THE PATIENT REMOVED THE CATHETER WITHOUT ANY DIFFICULTY AND WITH NO SITE REDNESS, SWELLING, OR DRAINAGE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 FROM THE PATIENT STATED THAT SHE WAS CURRENTLY IN STABLE CONDITION. THE PAIN WAS MINIMAL WITH NOT SIGNS OF ANY DRUG TOXICITY. SHE AWOKE ON SATURDAY MORNING, (B)(6) 2018 AND FELT THAT THE PUMP WAS LIGHTER. SHE DID NOT CHECK UNTIL NOON WHEN SHE REALIZED IT WAS EMPTY. THE PUMP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645737 ↗
• MalfunctionJun 19, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 600 ML, FLOW RATE: 8 ML/HR, PROCEDURE: ANKLE SURGERY, CATHPLACE: UNKNOWN, DATE/TIME WHEN INFUSION STARTED: (B)(6) 2018 2:00 PM, DATE/TIME WHEN INFUSION ENDED: (B)(6) 2018 8:00 PM. IT WAS REPORTED THE ONQ PUMP FINISHED IN 54-HOURS, SOONER THAN EXPECTED. THE PATIENT HAD SURGERY FROM 9:00 AM TO 12:00 PM AND THE PUMP WAS PLACED AT 2:00 PM ON MONDAY (B)(6) 2018. THE PATIENT NOTICED THE PUMP WAS EMPTY ON (B)(6) 2018 AT 8:00 PM. THE PATIENT STATED SHE NEVER CHANGED THE RATE FROM 8 ML/HR. THE PATIENT STATED SHE NEVER HAD ANY TOXICITY SIDE EFFECTS (HEART RACING, METAL TASTE IN MOUTH, RINGING IN EARS). THE PATIENT HAD ORDERS TO REMOVE THE PUMP WHEN IT WAS EMPTY. THE PATIENT REMOVED THE PUMP. THE PATIENT WAS INSTRUCTED TO FOLLOW-UP WITH THE ANESTHESIOLOGIST AND INSTRUCT THE PHYSICIAN THE PUMP FINISHED EARLY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7615975 ↗
• InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 6 ML/HR. PROCEDURE: ROTATOR CUFF/SLAP REPAIR CATHPLACE: NECK - NEXT TO JUGULAR. IT WAS REPORTED THAT A PATIENT EXPERIENCED A REACTION ASSOCIATED WITH THE USE OF AN ELASTOMERIC HOMEPUMP. IT WAS NOTED THAT THE PUMP WAS PARALYZING THE PATIENT¿S LUNGS AND DIAPHRAGM. IT HAD TO BE REMOVED SO THE PATIENT COULD BREATHE WHILE IN THE EMERGENCY ROOM (ER) FOR ABOUT 7 HOURS. THE PATIENT WAS ADMITTED DUE TO BREATHING ISSUES, DIZZINESS, DROWSINESS, AND OTHER UNSPECIFIED REASONS. ADDITIONAL INFORMATION RECEIVED ON 09-MAY-2018 STATED THAT THE PATIENT STARTED FEELING SIGNS AND SYMPTOMS OF SHORTNESS OF BREATH ON (B)(6) 2018, THURSDAY EVENING. THE PATIENT THOUGHT IT WAS SOME TYPE OF ALLERGY, SO HE USED NASOCORT FOR RELIEF, AND FELT BETTER AFTERWARD. THE NEXT MORNING ON (B)(6) 2018, WHEN THE PATIENT WAS CHANGING THE ICE ON THE MACHINE HOOKED TO HIS ARM, HE EXPERIENCED SHORTNESS OF BREATH AGAIN. HE CALLED HIS DOCTOR WHO INSTRUCTED HIM TO GO TO THE ER TO REMOVE THE CATHETER AND DISCONTINUE USAGE OF THE PUMP SINCE THE NERVE BLOCK MAY HAVE PARALYZED HIS LUNGS. IN THE ER, A CHEST X-RAY WAS PERFORMED AND SHOWED THAT THE PATIENT¿S LARYNX WAS PARALYZED, AND HIS DIAPHRAGM WAS LI

  Patient problems: Dizziness; No Code Available

  MAUDE report 7550556 ↗
• InjuryFeb 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 07-FEB-2018 STATED THAT THE PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT PROCEDURE WITH A LEFT INTERSCALENE CATHETER INSERTION SITE. THE FLOW RATE WAS SET TO 4 CC. THE PATIENT DID HAVE ANESTHETICS IN THE PAST BUT NO UNDERLYING MEDICAL CONDITIONS, BUT WAS ALSO ON NORCO IN ADDITION TO THE MEDICATION IN THE PUMP. IT WAS NOTED THAT NO MEDICAL INTERVENTION WAS REQUIRED FOR THE EVENT THE PATIENT EXPERIENCED.

  Patient problems: No Code Available; Numbness

  MAUDE report 7249033 ↗
• MalfunctionNov 27, 2017Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 600 ML. FLOW RATE: 6 ML/HR. PROCEDURE: SHOULDER REPLACEMENT. CATHPLACE: INTERSCALENE BLOCK/ SHOULDER. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED. THE PUMP WAS CONNECTED ON MONDAY, (B)(6) 2017, AT 6:30PM. THE PUMP WAS TO RUN AT 6CC/HR FOR 64 HOURS. ON (B)(6) 2017 THE PATIENT'S PAIN DEVICE APPEARED EMPTY. ADDITIONAL INFORMATION RECEIVED 13-NOV-2017 STATED THE DEVICE WAS NOT USED WITH ANY TYPE OF HEATING DEVICE. THE DEVICE WAS CARRIED ON THE PATIENT'S SHOULDER IN A FANNY BAG WHILE THE PATIENT WAS IN THE BED. THERE WAS NO REPORTED PATIENT INJURY. NO FURTHER INFORMATION TO BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7061613 ↗
• MalfunctionNov 22, 2017Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED VIA MEDWATCH, (B)(4), THAT, "PATIENT Q-BALL MEDICATION FOUND TO BE EMPTY." NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7054241 ↗
• MalfunctionOct 24, 2017Break

  PATIENT Q-BALL MEDICATION FOUND TO BE EMPTY. IT WAS LATER NOTED THAT THE CATHETER WAS BRITTLE AND BROKEN IN TWO.

  Patient problems: No Information

  MAUDE report 6972030 ↗
• InjuryApr 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 750 ML, FLOW RATE: 8-6 ML/HR, PROCEDURE: ROTATOR CUFF SURGERY, CATHPLACE: NECK. IT WAS REPORTED THAT A PATIENT WHO HAD ROTATOR CUFF SURGERY HAD AN ELASTOMERIC PUMP WITH A FLOW RATE THAT WAS INITIALLY SET TO 8 ML/HR AFTER THE SURGERY. HOWEVER, THE PATIENT EXPERIENCED SHORTNESS OF BREATH. IT WAS RECOMMENDED BY THE ANESTHESIOLOGIST THAT THE FLOW RATE OF THE PUMP BE DECREASED TO 6 ML/HR. TWO HOURS AFTER ADJUSTING THE FLOW RATE, THE PATIENT REPORTED THAT HE FELT BETTER. THE PUMP'S USE WAS CONTINUED UNTIL (B)(6) 2017.

  Patient problems: Dyspnea

  MAUDE report 6503346 ↗
• InjuryMar 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 700 ML, FLOW RATE: 6 ML/HR, PROCEDURE: ROTATOR CUFF REPAIR, CATHPLACE: NECK, DATE OF PROCEDURE: (B)(6) 2017. IT WAS REPORTED A PATIENT HAD SURGERY ON (B)(6) 2017, AND POST-SURGERY, THE PATIENT WOKE UP TO FEEL HER THROAT IN PAIN IN CONJUNCTION WITH DIFFICULTY BREATHING. THE HOSPITAL STAFF ADVISED THAT THIS WAS PART OF THE RECOVERY AND THE ISSUE WOULD RESOLVE IN TIME. THE PATIENT WAS DISCHARGED WITH THE ELASTOMERIC INFUSION PUMP, AND THE NEXT MORNING, HER FACE AND BODY WAS COVERED IN HIVES. SHE ALSO EXPERIENCED A SHORTNESS OF BREATH. THE PATIENT'S HUSBAND TOOK HER TO THE EMERGENCY ROOM (ER), AND WHILE EN-ROUTE TO THE ER, SHE TRIED TO ADJUST THE SELECT-A-FLOW (SAF) DIAL TO 0, BUT THE DIAL BROKE. THE PUMP WAS CLAMP UPON ARRIVING TO THE ER, AND SYMPTOMS BEGAN TO IMPROVE TWO HOURS AFTER CLAMPING. THE ER STAFF ADVISED THAT SHE WAS EXPERIENCING AN ALLERGIC REACTION, WHICH COULD POSSIBLY BE FROM THE MEDICATION IN THE ELASTOMERIC INFUSION PUMP. AS A RESULT, SHE RECEIVED ANTIHISTAMINES (BENADRYL), AND FLUID THERAPY TO FLUSH HER SYSTEM OUT. THE PUMP WAS NOT LABELLED WITH TYPE OF MEDICATION IT CONTAINED. ADDITIONAL INFORMATION RECEIVED ON 16-MAR-2017 STATED THAT IT WAS BELIEVED THA

  Patient problems: Dizziness; Dyspnea; Lethargy; Nausea; Reaction; Urticaria; Vomiting

  MAUDE report 6419169 ↗
• MalfunctionMar 10, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 750 ML, FLOW RATE: 8 ML/HR, PROCEDURE: PARTIAL KNEE REPLACEMENT, CATHPLACE: THIGH, INFUSION START TIME: (B)(6) 2017 AT 3PM, INFUSION STOP TIME: (B)(6) 2017 AT 4AM. IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ELASTOMERIC INFUSION PUMP THAT INFUSED TOO FAST. THE PUMP WAS PLACED ON (B)(6) 2017 AND WAS EMPTY BY (B)(6) 2017. IT WAS NOTED THAT THE PUMP LASTED 58-HOURS INSTEAD OF 90-HOURS AND WAS SET AT 8 ML/HR THE ENTIRE TIME. THERE WAS NO REPORTED PATIENT ADVERSE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6396621 ↗
• InjuryFeb 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 750 ML, FLOW RATE: 6 ML/HR, PROCEDURE: LEFT ROTATOR CUFF REPAIR, CATHPLACE: LEFT SHOULDER. IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT BEGAN TO EXPERIENCE A METALLIC TASTE IN HIS MOUTH ASSOCIATED WITH THE USE OF AN ELASTOMERIC HOMEPUMP. THE PATIENT NEVER EXPERIENCED ANY PRIOR SIDE EFFECTS UNTIL NOW. THE FLOW RATE WAS INITIALLY SET AT 6 ML/HR AND WAS NOT CHANGED. THE PATIENT WAS ADVISED TO CLAMP THE PUMP AND FOLLOW-UP WITH ANESTHESIA ON THE ISSUE. ANESTHESIA HAD THE PATIENT KEEP THE PUMP CLAMPED BECAUSE THEY HAD CONCERNS THAT THE CATHETER MAY HAVE MIGRATED. THEY WANTED TO PERFORM AN EVALUATION ON THE PATIENT AND PROPOSE THE POSSIBILITY OF REMOVING AND REINSERTING THE CATHETER. ADDITIONALLY, THEY WANTED TO DISCUSS WITH THE SURGEON AS TO WHY THE PATIENT WAS STILL EXPERIENCING SO MUCH PAIN SO LONG POST-OP. ADDITIONAL INFORMATION RECEIVED ON 01-FEB-2017 FROM THE PATIENT'S WIFE STATED THAT HER HUSBAND (PATIENT) WAS DOING WELL AND WAS IN STABLE CONDITION. HE WAS NO LONGER EXPERIENCING A METALLIC TASTE IN HIS MOUTH. IT RESOLVED 15 MINUTES AFTER THE PUMP WAS CLAMPED. HOWEVER, HE WAS STILL EXPERIENCING PAIN IN HIS LEFT SHOULDER, BUT IT IS NOTED TO BE MANAGEABLE. HE WA

  Patient problems: No Code Available

  MAUDE report 6362573 ↗
• MalfunctionJan 12, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML; FLOW RATE: 8 ML/HR; PROCEDURE: RIGHT KNEE SCOPE; CATHPLACE: GROIN. PUMP START TIME AND DATE: (B)(6) 2016 8:59 AM. PUMP END TIME AND DATE: (B)(6) 2016 1:00 AM. IT WAS REPORTED THAT A PATIENT WOKE UP IN THE MIDDLE OF THE NIGHT AND NOTICED THAT THE PUMP WAS EMPTY. THERE WERE NO REPORTED ADVERSE EFFECTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6247206 ↗
• InjuryJan 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: MANIPULATION OF ELBOW. A CAREGIVER REPORTED THAT SHE REMOVED THE PATIENT¿S PUMP BECAUSE OF IRRITATION TO THE AREA. AT THAT TIME, THE PUMP WAS ONLY HALF EMPTY. THE AREA AROUND THE DRESSING WAS RED, SWOLLEN, "RASHY", AND WARM TO THE TOUCH. THE CAREGIVER STATED THAT THERE WAS GREENISH PUS-LIKE DRAINAGE ON THE END OF THE CATHETER, AND THERE WAS AN ODOR TO IT. CURRENTLY, THERE IS CLEAR DRAINAGE COMING FROM THE INSERTION SITE. THE PATIENT¿S TEMPERATURE WAS NOTED AS 102 DEGREES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Fever; Irritation; No Code Available; Rash; Swelling; Unspecified Infection

  MAUDE report 6228204 ↗

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