Halyard 13548Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651135480), received between Jun 6, 2018 and Jun 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K052117); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: EAR INFECTION. CATH. PLACE: CENTRAL. INFUSION START TIME: (B)(6) 2018 10:00 PM. INFUSION STOP TIME: (B)(6) 2018 12:00 AM. IT WAS REPORTED THAT A (B)(6) CHILD EXPERIENCED THEIR HEAD TURNING RED WHILE USING AN ELASTOMERIC HOMEPUMP FILLED WITH VANCOMYCIN 132MG. IT WAS NOTED THAT THE PUMP WAS RUNNING TOO FAST. THE PUMP WAS EMPTY UPON DISCONNECTION. FURTHER INFORMATION NOTED THAT THE PUMP RAN OVER THE COURSE OF ONE HOUR. THE ORDER WAS CHANGED FOR THE PUMP TO RUN TWO HOURS FOR THE PATIENT THE PREVIOUS DAY. THE PATIENT EXPERIENCED HER HEAD TURNING RED THE NEXT DAY. DURING THE CALL TO REPORT THIS ISSUE, THE PATIENT¿S HEAD WAS NO LONGER RED. THE ORDER WAS FOR THE PATIENT TO RECEIVE INFUSION OF VANCOMYCIN 132MG OVER TWO HOURS. THE RATE WAS UNKNOWN. THE PATIENT¿S CONDITION AFTER THE EVENT WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON 22-MAY-2018 STATED THAT THIS EVENT WAS A FAST FLOW ISSUE. THE PUMP USED ON THE BABY WAS ORDERED FOR TWO HOURS, AND IT ONLY RAN FOR OVER AN HOUR. THE BABY EXPERIENCED RED HEAD SYNDROME, BUT THE REACTION DISSIPATED. ADDITIONAL INFORMATION RECEIVED ON 30-MAY-2018 STATED THAT THE BALL INFUSED WITH V

  Patient problems: No Code Available

  MAUDE report 7575630 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052117. One submission often covers many models, so check the product and lot details in each record.

• Z-2111-2009 · Feb 11, 2008 · Terminated
  I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medicatio
• Z-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump
• Z-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump