Halyard 13474Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10680651134742), received between Jan 5, 2017 and Apr 2, 2018 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT AN ELASTOMERIC PUMP DELIVERED SOLUTION FASTER THAN EXPECTED. THE RED TAB ON THE BOLUS WAS NOT REMOVED. HOWEVER, THE PATIENT WAS REPORTED TO HAVE NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7388301 ↗
• MalfunctionOct 12, 2017Mechanical Problem; Device Operational Issue; Mechanical Problem; Device Operational Issue

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2017-00179 FOR THE FIRST PATIENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: FEMORAL, CATHPLACE: INTERSCALENE, INFUSION START TIME: 09/18/17 @ 1109, INFUSION END TIME: UNKNOWN. IT WAS REPORTED THAT A PUMP HAD A BOLUS CHAMBER THAT WOULD NOT REFILL. IT WAS CONNECTED TO A PATIENT THE PREVIOUS DAY, AND THE PUMP HAD TO BE REPLACED THE MORNING OF (B)(6) 2017. THE BOLUS BUTTON WAS DEPRESSED MULTIPLE TIMES, REPORTED TO BE STUCK, AND DID NOT POP BACK UP WITHIN 30 MINUTES THE BOLUS BUTTON DID NOT LATCH ALL DURING THE NIGHT AND WHEN IT WAS CHECKED BY THE POST-ANESTHESIA CARE UNIT AT 0830 AM ON (B)(6) 2017. THE YELLOW INDICATOR WAS LOCATED AT THE BOTTOM POSITION NEAR THE TUBING. THERE WERE NO REPORTED CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945930 ↗
• MalfunctionOct 12, 2017Mechanical Problem; Device Operational Issue; Mechanical Problem; Device Operational Issue

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2017-00178 FOR THE SECOND PATIENT. FILL VOLUME: 550 ML, PROCEDURE: INTERSCALENE, NFUSION START TIME: (B)(6) 2017 @ 0849. IT WAS REPORTED THAT A PUMP HAD A BOLUS CHAMBER THAT WOULD NOT REFILL AFTER 50 MINUTES. THE PUMP AND BALL WERE CONNECTED TO A PATIENT. THE BOLUS BUTTON WAS DEPRESSED ONCE, REPORTED TO BE STUCK, AND DID NOT POP BACK UP WITHIN 30 MINUTES. IT WAS NOTED TO STILL BE STUCK AT 0945. THE BOLUS BUTTON DID NOT LATCH AND THE YELLOW INDICATOR WAS LOCATED AT THE BOTTOM POSITION NEAR THE TUBING. THERE WERE NO REPORTED CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945922 ↗
• MalfunctionAug 25, 2017Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN FLOW RATE: UNKNOWN PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN IT WAS REPORTED THAT THE PUMP DELIVERED THE FULL VOLUME OF 0.2% ROPIVACAINE WITHIN 24-HOURS AND THE RED TAB ON THE BOLUS HAD NOT BEEN REMOVED WHILE THE DEVICE WAS IN USE. ADDITIONALLY, THE NURSE SPOKE TO ANESTHETIST AND DETERMINED THAT THE RED TAB ON THE BOLUS HAD NOT BEEN REMOVED AND THE PUMP HAD DELIVERED THE FULL VOLUME OF 0.2% ROPIVACAINE WITHIN 24-HOURS. THE INFUSION WAS STOPPED IMMEDIATELY AND THE PATIENT UNDERWENT TOXICITY TESTING. THE PATIENT RECOVERED WITH NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6822976 ↗
• InjuryApr 4, 2017Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 500ML, FLOW RATE: 4 ML/HR, PROCEDURE: RIGHT ANKLE ARTHROPLASTY, CATHPLACE: UNKNOWN. START INFUSION TIME (B)(6) 2017, 10 AM, FINISHED EMPTY (B)(6) 2017, 9AM. A REPORT WAS RECEIVED STATING THE RED PRIMING KEY ON CB006 WAS NOT REMOVED BEFORE USE SO THE PUMP WAS FREE FLOWING DURING PATIENT USE. THE PUMP WAS FILLED IN THE FACILITY PHARMACY. THEY TESTED THE PUMP BY REFILLING IT WITH SALINE. SAMPLE IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED 10-MAR-2017 STATED A PATIENT AT THE HOSPITAL RECEIVED AN ONDEMAND PUMP THAT WAS FILLED TO 500ML. THIS VOLUME WAS EMPTIED OVER 1 DAY. AT THE INCIDENT TIME THE PATIENT HAD SYMPTOMS OF TOXICITY. A ¿STROKE CODE¿ WAS CALLED. THEN IT WAS NOTICED THE PUMP WAS COMPLETELY EMPTY. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU). IT IS UNKNOWN IF LIPID TREATMENT WAS NEEDED. THE HOSPITAL REALIZED THAT THE PUMP EMPTIED FAST BECAUSE THE RED PRIMING KEY OF THE ONDEMAND UNIT WAS NOT REMOVED. ADDITIONAL INFORMATION RECEIVED 13-MAR-2017 STATED THE PATIENT PRESENTED WITH CAL ANESTHETIC SYMPTOMS, FACIAL NUMBNESS, DIFFICULTY SPEAKING, NUMBNESS ON THE RIGHT SIDE OF BODY. THE PATIENT WAS SENT TO ICU FOR LIPID INFUSION. SINGLE SHOT NERVE BLOCK DURING S

  Patient problems: Dysphasia; Numbness

  MAUDE report 6457577 ↗
• MalfunctionFeb 16, 2017Sticking; Sticking

  IT WAS REPORTED THAT AN ELASTOMERIC HOMEPUMP HAD A BOLUS BUTTON STUCK IN THE DOWN POSITION. THE PUMP WAS CONNECTED TO A PATIENT BY A NURSE. DURING THE CONNECTION, THE NURSE PUSHED THE BUTTON TO GIVE THE PATIENT THE FIRST ONDEMAND DOSAGE. THE BUTTON REMAINED IN THE DOWN POSITION UPON PUSHING AND DID NOT RETURN TO ITS ORIGINAL UPWARD POSITION. THE PUMP WAS IMMEDIATELY REMOVED FROM THE PATIENT. IT WAS NOTED THAT AN ORANGE PIECE COULD BE SEEN INSIDE THE ONDEMAND UNIT. A PHOTO RECEIVED FROM THE INITIAL REPORTER DISPLAYED THE ORANGE (YELLOW) INDICATOR AT THE BOTTOM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6337118 ↗
• MalfunctionFeb 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS INITIALLY REPORTED ON (B)(6) 2017 THAT BOLUS BUTTON ON A HOMEPUMP WAS NOT FUNCTIONING; THE BUTTON WOULD NOT STAY DOWN. THE REPORTER NOTED THAT THEY COULD SEE A RED PIECE SHOWING. THERE WAS NO REPORTED PATIENT USE. ADDITIONAL INFORMATION RECEIVED ON 19-JAN-2017 STATED THAT THE PUMP WAS CONNECTED TO A PATIENT. WHEN THE NURSE TESTED THE BOLUS BUTTON FOR THE FIRST TIME USE, THE BUTTON WOULD REMAIN IN THE DOWN POSITION. THE PUMP WAS IMMEDIATELY REMOVED FROM THE PATIENT, WITH NO PATIENT INJURY REPORTED. THE PUMP WAS NOTED AS FULL OF MEDICATION AT THE TIME. A PHOTO RECEIVED FROM THE REPORTER DISPLAYED THE ¿RED PIECE¿ IN THE RESERVOIR WINDOW INSTEAD OF WHERE THE RED PRIMING KEY WAS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6322142 ↗
• InjuryJan 10, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: ROTATOR CUFF REPAIR, CATHPLACE: ISB. IT WAS REPORTED THAT A BASAL AND PCA PUMP WAS USED ON A PATIENT ON FRIDAY. THE PATIENT WENT TO THE EMERGENCY ROOM LAST NIGHT WITH A SEIZURE. THE CAREGIVER FOR THE PATIENT STATED THAT THE BALL WAS FULL, THEN ABOUT AN HOUR LATER AROUND MIDNIGHT, IT WAS COMPLETELY EMPTY. THE PUMP WAS REPORTED TO BE SET AT 6 ML/HR WITH THE BASAL OPTION AT 5 ML EVERY 30 MINUTES. THE PUMP WAS CONNECTED AROUND 3PM ON FRIDAY, AND THE SEIZURE WAS LAST NIGHT AT ABOUT MIDNIGHT, WHICH IS APPROXIMATELY 33 HOURS. IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. NO FURTHER INFORMATION REGARDING THE EVENT HAS BEEN RECEIVED.

  Patient problems: Seizures

  MAUDE report 6237575 ↗
• MalfunctionJan 5, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML, FLOW RATE: 4 ML/HR, PROCEDURE: SHOULDER SCOPE WITH LEFT ACROMIOPLASTY FOR LEFT ROTATOR CUFF TEAR, CATHPLACE: INTERSCALENE BLOCK. IT WAS REPORTED THAT A 400 ML TITRATABLE BOLUS PUMP WAS PLACED FOR AN INTERSCALENE BLOCK FOR A TOTAL SHOULDER REPLACEMENT PROCEDURE. THE PATIENT WAS SENT HOME WITH THE PUMP ON (B)(6) 2016, AND THEY REPORTED TO ANESTHESIA THAT THE PUMP WAS EMPTY ON (B)(6) 2016. THE BOLUS BUTTON WAS NOTED AS NOT USED. THERE WAS NO PATIENT INJURY AND NO REPORTED ADVERSE EVENTS. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PUMP WAS STARTED AROUND 12:30 PM ON A MONDAY, AND IT WAS EMPTY AROUND NOON ON TUESDAY. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE SYMPTOMS. THE PUMP WAS FILLED AT A HOSPITAL PHARMACY AND THE RED PRIMING KEY WAS NOT REMOVED. THE PUMP WAS NOT PLACED AT A SITE HIGHER THAN THE INFUSION LOCATION AND THERE WAS NO REPORTED HEAT OR PRESSURE APPLIED ON THE PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6226973 ↗

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