Halyard 31614Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651316148), received between May 22, 2017 and May 22, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 400 ML, FLOW RATE: 7 ML/HR, PROCEDURE: A LAP / CONVERTED TO OPEN ULTRA LOW HARTMANN'S PROCEDURE PLUS, EXTERIORIZATION OF THE BOWEL, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A PATIENT HAD A LAP / CONVERTED TO OPEN ULTRA LOW HARTMANN'S PROCEDURE PLUS EXTERIORIZATION OF THE BOWEL AND HAD AN ELASTOMERIC PUMP PLACED. THE PUMP WAS STARTED AT 19.30 ON (B)(6), AND AT 16.00 ON FRIDAY, IT WAS NOTED THAT THE PUMP WAS EMPTY. THE PUMP WAS EXPECTED TO LAST APPROXIMATELY 28 HOURS, BUT IT COMPLETED IN 20 HOURS. THE PUMP IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED OF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6581468 ↗
• InjuryMay 22, 2017Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550 ML, FLOW RATE: 4 ML/HR + 4 ML/HR, PROCEDURE: BREAST IMPLANT PROCEDURE, CATHPLACE: BILATERAL BREAST, PUMP START TIME: 10 AM ON (B)(6) 2017, PUMP STOP TIME: 5 OR 6 PM ON (B)(6) 2017. IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT HAD BREAST IMPLANT SURGERY ON (B)(6) 2017, AND ON (B)(6) 2017, THE PATIENT EXPERIENCED PAIN WHILE LAYING DOWN. IT WAS NOTICED THAT THE ELASTOMERIC PUMP WAS COMPLETELY EMPTY, AND THE TIME WAS NOTED TO BE AROUND 5-6 PM. AT THE SAME TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF DIZZINESS, NUMBNESS TO HER ARM, PAIN, AND DIFFICULTY BREATHING. THE NEXT DAY, THE PATIENT'S MOTHER CALLED THE DOCTOR TO INFORM HER OF THE PUMP ISSUE AND ASSOCIATED SYMPTOMS. THE PATIENT WAS SEEN BY THE DOCTOR THE SAME DAY, AND A HEMATOMA WAS DISCOVERED ON HER LEFT BREAST IN THE AREA OF THE CATHETER INSERTION SITE. THE PUMP WAS DUE TO LAST 50 HOURS, BUT IT COMPLETED IN LESS THAN 24 HOURS. ACCORDING TO THE DOCTOR, THE HEMATOMA WAS CAUSED BY THE FAST FLOW OF FLUID CAUSING HIGH PRESSURE INTO THE PATIENT'S BREAST. THE PUMP WAS REMOVED ON (B)(6) 2017. THE PATIENT HAD A SECOND SURGERY (B)(6) 2017 TO DRAIN THE HEMATOMA SITE. THE PATIENT'S SYMPTOMS DISSIPATED AFTER

  Patient problems: Dizziness; Hematoma; No Code Available; Numbness; Pain

  MAUDE report 6581461 ↗

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