Halyard 13477Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10680651134773), received between May 12, 2017 and Nov 21, 2019 — classified as 1 death, 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. START DATE/TIME OF INFUSION ¿ FRIDAY, (B)(6) 2019, 3PM. STOP DATE/TIME OF INFUSION ¿ MONDAY, (B)(6) 2019, 10AM. IT WAS REPORTED THE PATIENT EXPERIENCED HYPOTENSION AND WAS LETHARGIC WHEN THE DEVICE WAS IN USE. THE SYMPTOMS STARTED WITH INITIATION OF THE THERAPY AND WERE RESOLVED WITH DISCONTINUATION OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED 05-NOV-2019 STATED THE "PATIENT HAD A TOXICITY REACTION SO THERE WAS CONCERN THAT THE PUMP WAS IN A FAST FLOW STATE."

  Patient problems: Lethargy; Low Blood Pressure/ Hypotension

  MAUDE report 9358181 ↗
• MalfunctionSep 13, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML, FLOW RATE: 7 ML/HR, PROCEDURE: PEDIATRIC CARDIAC, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PATIENT'S PUMP, FILLED WITH 600ML LOCAL ANESTHETIC SOLUTION, RAN THROUGH IN UNDER 30 HOURS WHEN IT WAS EXPECTED TO FUN FOR 42 HOURS AT 7ML/HR/CATHETER. "INVESTIGATIONS AND DISCUSSIONS WITH THE STAFF FILLING AND CHECKING THE DEVICE IN THEATRE (NURSING AND ANESTHETIC STAFF) SUGGESTS IT IS UNLIKELY TO BE AN UNDER-FILL ISSUE DUE TO THE ROBUST PROCESS EMPLOYED ON A REGULAR BASIS HOWEVER IT CANNOT BE RULED OUT COMPLETELY. INVESTIGATIONS OF CARE GIVEN WHILE IN PICU [PEDIATRIC INTENSIVE CARE UNIT] AND 10B APPEAR ALL APPROPRIATE." NO PATIENT ADVERSE EFFECTS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9024770 ↗
• MalfunctionAug 26, 2019Infusion or Flow Problem; Infusion or Flow Problem

  PER ADDITIONAL INFORMATION RECEIVED 22 AUG 2019, THE DEVICE WAS FILLED WITH 600ML LOCAL ANESTHETIC AND WAS FINISHED IN 40 HOURS INSTEAD OF THE 60 HOURS IT WAS EXPECTED TO LAST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8930610 ↗
• MalfunctionOct 12, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 750 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: BILATERAL TAP. IT WAS REPORTED THE NURSE FROM THE ANESTHESIA GROUP AT THE HOSPITAL REPORTED THAT SHE SUSPECTS A PUMP INFUSED QUICKER THAN EXPECTED ON A PATIENT. THE PATIENT HAD BILATERAL TAP CATHETERS PLACED ON (B)(6) 2018. THERE WAS NO REPORTED PATIENT INJURY. THE EXACT TIME OF WHEN THE PUMP WAS STARTED OR WHEN THE INFUSION ENDED WAS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7962490 ↗
• DeathOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 12 ML/HR (6 ML PER SIDE). PROCEDURE: BI-LATERAL NEPHRECTOMY. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT DIED. IT WAS A PEDIATRIC PATIENT THAT HAD AN ON-Q ELASTOMERIC PUMP PLACED. THE HOSPITAL DOES NOT CONFIRM THAT THE ON-Q ELASTOMERIC PUMP IS RESPONSIBLE, BUT IS CONSIDERING LOCAL ANESTHETIC TOXICITY AS A POTENTIAL CAUSE. THE PUMP WAS NOT SAVED BECAUSE IT WAS DISCONNECTED SEVERAL HOURS PRIOR TO PATIENT DEATH. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Death

  MAUDE report 7955760 ↗
• MalfunctionJul 6, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML, FLOW RATE: 7 ML/HR + 7 ML/HR = 14 ML/HR, PROCEDURE: RIB FRACTURE PLATING, CATHPLACE: RIGHT SIDE RIBS. IT WAS REPORTED THAT A PATIENT EXPERIENCED A FAST FLOW INFUSION. THE PUMP WAS STILL ATTACHED TO THE PATIENT AT THE TIME OF THE REPORT, BUT THE FLOW RATE WAS ADJUSTED TO A VERY LOW RATE. THE PATIENT WAS BEING MONITORED BY VITALS, AND AT THE TIME, THERE WERE NO SIGNS OR SYMPTOMS OF TOXICITY OR PATIENT INJURY. THE PUMP WAS NOTED TO BE UNDER A BLANKET SINCE THE PATIENT WAS USING A BAIR HUGGER. THE PUMP WAS SET TO LAST 42-HOURS, BUT AFTER 24-HOURS, THE PUMP HAD ONLY ABOUT 100 ML.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7667660 ↗
• MalfunctionJun 25, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 750 ML, FLOW RATE: UNKNOWN, PROCEDURE: GASTRIC BYPASS PROCEDURE, CATHPLACE: TWO BOTH NEAR THE TRANVERSE ABDOMINAL PLANE, DATE OF PROCEDURE: (B)(6) 2018. IT WAS REPORTED THE SURGEON WAS PERFORMING ROUNDS ON THE PATIENT WHEN SHE NOTICED THAT THE PUMP "SEEMED SMALLER THAN USUAL." THE PUMP WAS IN AN ON-Q CARRYING BAG AND WAS ON THE BED NEXT TO THE PATIENT DURING INFUSION. THERE WAS NO PATIENT REPORTED INJURY. IT WAS UNKNOWN IF THE PATIENT ADDED EXTERNAL PRESSURE TO THE PUMP OR IF THE PATIENT WAS USING ANY WARMING DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636183 ↗
• InjuryMay 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 700 ML, FLOW RATE: 1 TO 3 ML/HR, PROCEDURE: PEDIATRIC VATS PERFORMED ON (B)(6) 2018, CATHPLACE: TOP OF THE RIBS. IT WAS REPORTED THE PATIENT EXPERIENCED SUSTAINED AXILLARY NERVE APRAXIA AFTER THE USE OF THE PUMP. THE DOCTORS WERE NOT SURE IF THE USE OF THE PUMP AND CATHETER CONTRIBUTED TO THE SYMPTOMS. THE PATIENT WAS NOT SURE WHEN THE SYMPTOMS STARTED DURING THE INFUSION PROCESS. THE DEVICE WAS REMOVED ON (B)(6) 2018. THE NEUROLOGY TEAM WAS CONSULTED AND PHYSICAL THERAPY (PT) WAS INITIATED PRIOR TO TRANSFER OF THE PATIENT. NO ADDITIONAL INFORMATION.

  Patient problems: No Code Available

  MAUDE report 7494622 ↗
• MalfunctionApr 6, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: 6 ML/HR, PROCEDURE: MIDLINE LAPAROTOMY, CATHPLACE: INCISION. IT WAS REPORTED THAT AN ELASTOMERIC PUMP WAS TITRATED TO 6 ML/HR AND IT EMPTIED IN 24 HOURS. THE PUMP WAS INCISIONALLY PLACED FOR A MIDLINE LAPAROTOMY. THE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7404671 ↗
• MalfunctionMar 16, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 750 ML, FLOW RATE: 7 ML/HR, PROCEDURE: SPINAL FUSION - 7 ML¿S . IT WAS REPORTED BY THE CUSTOMER WHO STATED, I WAS NOTIFIED THIS MORNING THAT A PATIENT¿S PUMP INFUSED IN UNDER 48-HOURS. IT WAS INFUSING AT 7 ML¿S PER HOUR PER SIDE. THE PATIENT WAS NOT INJURED. THE CLINICIANS REMOVED THE DEVICE AND CONNECTED A SECOND PUMP. THE PATIENT WAS COMPLAINING OF NO PAIN AT THE TIME. THE PUMP WAS PLACED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7344616 ↗
• MalfunctionJan 4, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 600 ML, FLOW RATE: 14 ML/HR, PROCEDURE: SPINAL FUSION, CATHPLACE: BACK. IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT WAS IN EXTREME PAIN AND SAYING THAT THE PUMP WAS EMPTY. THE PATIENT'S WIFE HAD TO INTERPRET FOR THE PATIENT SINCE HE WAS IN TOO MUCH PAIN. IT WAS STATED THAT THE 600 ML PUMP WAS COMPLETELY EMPTY (EMPTIED IN 60 HOURS) AND THEY WERE CONCERNED THAT IT INFUSED TOO QUICKLY. THE PUMP WAS SET AT 5-7 ML AT EACH PORT FOR A TOTAL OF 10-14 ML-HR. IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO GET PAIN MEDICATION AS WELL. THE PAIN WAS STATED TO BE 10/10. THE PATIENT WAS OTHERWISE STABLE AND THERE WERE NO COMPLAINTS OF SIDE EFFECTS FROM THE MEDICATION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 7164875 ↗
• InjuryAug 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 600 ML, FLOW RATE: 7+7 ML/HR, PROCEDURE: TOTAL HYSTERECTOMY, CATHPLACE: BILATERAL MIDLINE SUBFASCIAL. IT WAS REPORTED THAT A PATIENT WAS READMITTED TO THE HOSPITAL FOR NECROTIZING FASCIITIS. THE PATIENT PRESENTED IN THE EMERGENCY ROOM A WEEK AFTER HER SURGERY. THE PATIENT WAS EDUCATED BEFORE HER DISCHARGE ON PULLING THE CATHETERS AT HOME. THE PATIENT COMPLAINED OF RIGHT FLANK PAIN AND A DISTENDED BELLY. THERE WAS NO REDNESS AT THE CATHETER SITE. ADDITIONAL INFORMATION RECEIVED ON 19-JUL-2017 STATED THAT THE PATIENT HAD A TOTAL HYSTERECTOMY (B)(6) 2017. THE PATIENT COMPLAINED OF RIGHT FLANK PAIN AND HAD A DISTENDED BELLY SO SHE WAS TREATED WITH A GAS MEDICATION FIRST. IT WAS NOT UNTIL (B)(6) 2017 THAT THE PATIENT WAS READMITTED FOR AN INFECTION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 6770480 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 700 ML. FLOW RATE: 4 ML/HR. PROCEDURE: DOUBLE MASTECTOMY. CATHPLACE: UNDER PATIENT'S BREASTS. IT WAS REPORTED BY THE PATIENT'S HUSBAND THAT HIS WIFE'S BREATH HAD A DIFFERENT SMELL. THE PATIENT DID NOT DESCRIBE THE TASTE SHE EXPERIENCED AS BEING METALLIC, BUT SHE DID CONFIRM TO HAVE A MILD RINGING OF THE EARS. SHE WAS INSTRUCTED TO CLAMP THE PUMP'S TUBING AND CALL THEIR SURGEON. THE SURGEON ADVISED THEM TO CONTINUE USE THE PUMP AND THAT HE WOULD REMOVE IT ON TUESDAY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 FROM THE PATIENT'S HUSBAND STATED THAT THE PATIENT IS DOING WELL AND WAS IN STABLE CONDITION. ON THE DAY OF THE EVENT, THE PUMP WAS CLAMPED THE STOP THE INFUSION. THE NEXT DAY, THE PATIENT WAS DOING OK. HOWEVER, WHEN THE PUMP WAS CLAMPED, THE PUMP WAS REPORTED TO HAVE MEDICATION THAT REMAINED. IT WAS NOTED THAT DURING THE PATIENT'S FOLLOW-UP APPOINTMENT WITH THE PLASTIC SURGEON ON (B)(6)2017, THE PUMP STILL HAD MEDICATION THAT REMAINED IN IT WHEN IT WAS REMOVED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 FROM THE PATIENT STATED THAT SHE IS DOING WELL AND IS NO LONGER EXPERIENCING THE METAL TASTE, METAL SMELL, AND RINGING IN HER EARS. SHE STATED SHE CLAMPED

  Patient problems: No Code Available; Tinnitus

  MAUDE report 6696837 ↗
• InjuryMay 12, 2017Excess Flow or Over-Infusion; Shelf Life Exceeded; Excess Flow or Over-Infusion; Shelf Life Exceeded

  FILL VOLUME: 600 ML, FLOW RATE: 4 ML/HR, PROCEDURE: LAPAROSCOPY, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT EXPERIENCED METALLIC TASTE AND NUMBNESS DOWN THE BACK OF HER LEG ASSOCIATED WITH THE USE OF AN ELASTOMERIC HOME PUMP. IT WAS NOTED THAT THE PUMP COMPLETED INFUSION EARLIER THAN EXPECTED, BUT WAS SUPPOSED TO LAST FIVE DAYS. THE PUMP DIAL WAS SET AT 4, AND THE DIAL HOLDER WAS ZIP TIED SHUT. THE PATIENT'S PAIN WAS A 0/10. THE PATIENT WAS ADVISED TO CLAMP THE PUMP AND CALL HER SURGEON. THE PATIENT SPOKE TO THE SURGEON AND WAS ADVISED TO KEEP HER INFORMED IF THE SYMPTOMS INCREASE. HOWEVER, THE METALLIC TASTE DISSIPATED AND THE NUMBNESS IN THE LEG LESSENED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Code Available; Numbness

  MAUDE report 6563914 ↗

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