BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PULSAVAC PLUS HIP KIT

    MDR report key: 3982991 · Received July 2, 2014

    Report

    Report Number
    1526350-2014-00387
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED. THE MOST LIKELY CAUSE FOR THE BATTERIES TO EXPLODE, AS DEFINED BY THE WARNING INSTRUCTIONS FROM THE BATTERY MANUFACTURER IS FOR THE BATTERIES TO SHORT OUT OR TO DEVELOP EXCESSIVE HEAT WHEREBY CAUSING A FIRE TO INITIATE THE EXPLOSION. BASED ON THE CUSTOMER'S REPORT THAT THE DEVICE WAS BURNT IT IS MOST PROBABLE THAT THE DEVICE CAUSED A SMALL FIRE. THE CONDITIONS AT THE TIME OF THE INCIDENT AND THE CONTENTS OF THE MEDICAL WASTE CONTAINER ARE UNKNOWN. HOWEVER, THE POTENTIAL FOR THE BATTERIES TO EXPLODE IS ADDRESSED IN THE IFU AND IN THE RISK ASSESSMENT. CONJECTURE INDICATES THAT WHEN THE DEVICE WAS DISCARDED, THE TRIGGER WAS BUMPED AND ACTIVATED THE DEVICE. THE DEVICE WHEN ACTIVATED WOULD CAUSE THE DEVICE TO EXPEL THE LIQUID THAT REMAINED IN THE TUBING. ANY LIQUID CONTACT HAS THE POTENTIAL TO SHORT THE BATTERY PACK CAUSING IT TO HEAT UP. THE ROOT CAUSE OF THIS INCIDENT IS MOST LIKELY THE IMPROPER DISPOSAL OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SURGERY, THE ZIMMER PULSAVAC PLUS HIP KIT EXPLODED TWICE IN THE MEDICAL GARBAGE BIN AFTER IT WAS DISPOSED OF AND THE BIN HAS CHANGED SHAPE. ADDITIONALLY, WHEN THE DEVICE WAS PUT IN THE GARBAGE BIN, IT STARTED TO MOVE. NO INFLAMMABLE THINGS WERE IN THE BIN. THE PRODUCT WAS DISPOSED OF BY THE CUSTOMER BECAUSE IT WAS BURNED. THERE WAS NO PATIENT/USER HARM OR DELAY OF THE SURGERY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388493 ZIMMER PULSAVAC PLUS HIP KIT ZIMMER PULSAVAC PLUS HIP KIT FQH ZIMMER SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1