BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN SPRAY KIT

    MDR report key: 5587078 · Received April 19, 2016

    Report

    Report Number
    0001526350-2016-00042
    Event Type
    Malfunction
    Date Received
    April 19, 2016
    Report Date
    May 9, 2016
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED FOR PART NUMBER 00-5150-475-01, LOT 63171221. THIS DEVICE WAS MANUFACTURED AT ZIMMER SURGICAL AND PLACED INTO INVENTORY ON (B)(4) 2015. THERE WERE NO RELATED NON-CONFORMANCES OR REQUEST FOR DEVIATIONS (RFD) REPORTED. ENERGIZER ¿AA¿ BATTERIES PART NUMBER 06-0013-050-63 FROM LOT NUMBER 80695117 WERE USED IN THE ASSEMBLY OF THE REFERENCED PULSAVACS. THESE BATTERIES WERE CERTIFIED BY THE SUPPLIER AND PLACED INTO ZIMMER SURGICAL INVENTORY ON (B)(4) 2015. THE SHELF LIFE FOR THIS LOT WAS THROUGH DEC-2025. NO NON-CONFORMANCES WERE DISCOVERED FOR BATTERIES FROM THIS LOT IN INCOMING INSPECTION OR FROM THE ASSEMBLY/TEST AREA. ON (B)(4) 2016 A SINGLE BATTERY PACK LID WAS RETURNED IN A CARDBOARD BOX. A TYVEK LID WAS INCLUDED THAT NOTED THE TRACE LOT NUMBER. VISUAL INSPECTION NOTED A SMALL AMOUNT CHARRING ON THE UNDERSIDE OF THE BATTERY PACK LID. NOTHING ELSE WAS RETURNED FOR EVALUATION. THE VISUAL INSPECTION FOUND THE DISCOLORATION ON THE UNDERSIDE OF THE BATTERY LID. THIS COULD INDICATE THAT THE BATTERIES GOT HOT. SINCE IT WAS NOT REPORTED THAT THE BATTERIES HAD SPLIT OPEN OR EXPERIENCED AN ANODE EXPULSION, WE CAN CONCLUDED THAT THE BATTERIES DID NOT OVER HEAT TO A CATASTROPHIC FAILURE. THERE ARE SEVERAL REASONS THAT THE BATTERIES COULD HEAT UP. HOWEVER, THE MOST LIKELY CAUSE FOR BATTERY OVERHEATING IS A SHORT CIRCUIT. HISTORICALLY, COMPLAINTS FOR THIS REPORTED EVENT IS DUE TO THE USER SEVERING THE ELECTRICAL CABLE FROM THE HAND PIECE AFTER SURGERY (WHICH IS NOW A BIOHAZARD) TO ISOLATE THE BATTERY PACK FOR LATER BATTERY REMOVAL. THIS CUTTING OF THE BATTERY CABLE CAN INDUCE A SHORT CIRCUIT CAUSING THE BATTERIES TO OVERHEAT. GIVEN ENOUGH TIME THE GAS BUILD UP IN THE BATTERIES CAN CAUSE AN ANODE EXPULSION SO IT APPEARS THAT THE BATTERY PACK EXPLODED. THE DEVICE INSTRUCTIONS FOR USE AND THE LABELING ON THE TYVEK LID WARN THAT CUTTING THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS, AND COULD RESULT IN FIRE OR PERSONAL INJURY. THE BATTERIES SHOULD BE PHYSICALLY REMOVED FROM THE BATTERY PACK, CARE SHOULD BE TAKEN AND PERSONAL SAFETY EQUIPMENT SHOULD BE WORN. THE INSTRUCTIONS FOR USE (IFU) EXPLICITLY STATES: WARNINGS: EXPLOSION HAZARD. DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS OR GASES. DO NOT SUBMERGE HANDLE IN LIQUID AS THIS MAY COMPROMISE THE EFFICIENCY OF THE PUMP OR ALTER THE PH OF THE LIQUID. DO NOT CUT THE BATTERY PACK CABLE. CUTTING THROUGH THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS, AND COULD RESULT IN FIRE AND/OR PERSONAL INJURY. DO NOT SUBMERGE THE BATTERY PACK IN LIQUID. ADDITIONALLY, THE TYVEK LID FOR THE INDIVIDUAL PULSAVACS DEVICES STATES: WARNING: EXPLOSION HAZARD. DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS OR GASES. DO NOT SUBMERGE IN LIQUID AS THIS MAY COMPROMISE THE EFFICIENCY OF THE PUMP OR ALTER THE PH OF THE LIQUID. DO NOT CUT THE BATTERY PACK CABLE. CUTTING THROUGH THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS, AND COULD RESULT IN FIRE AND/OR PERSONAL INJURY. DO NO SUBMERGE THE BATTERY PACK IN LIQUID. USE CAUTION WHEN REMOVING BATTERIES. THE BATTERY PACK CONTAINS ALKALINE BATTERIES. EXPOSURE TO THE CONTENTS OF AN OPEN OR LEAKING BATTERY OR THEIR COMBUSTION PRODUCTS COULD BE HARMFUL. AVOID SKIN AND EYE CONTACT. USE NEOPRENE OR NATURAL RUBBER GLOVES AND SAFETY GLASSES WITH SIDE SHIELDS WHEN HANDLING BATTERIES. THE MOST LIKELY CAUSE FOR THIS INCIDENT IS IMPROPER DISPOSAL OF THE DEVICE IN CONTRADICTION OF THE IFU WARNINGS BY THE CUSTOMER. RECOMMENDED ACTIONS: THE CUSTOMER¿S PERSONNEL SHOULD HAVE REFRESHER TRAINING ON THE IFU FOR THIS PRODUCT. THE ELECTRICAL WIRES OF THIS DEVICE SHOULD NEVER BE CUT OR PULLED OUT WITHOUT THE BATTERIES BEING REMOVED FIRST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSAVAC OVERHEATED. FURTHER INFORMATION WAS RECEIVED STATING THAT WHEN REMOVING THE CASING IN ORDER TO REMOVE THE BATTERIES, SOME CHARRING WAS FOUND WHEN THE STAFF MEMBER REMOVED THE CASING IN ORDER TO REMOVE THE BATTERIES. THERE WAS NO HARM, INJURY OR ADVERSE EVENT TO PATIENT/OPERATOR AND THE LIFE/HEALTH OF THE PATIENT WAS NOT AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242431 FAN SPRAY KIT DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM FQH ZIMMER SURGICAL, INC. N/A 63171221

    Patients

    Seq Age Sex Outcome Treatment
    1