BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLO-GARD 6200 PUMP

    MDR report key: 1822942 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02916
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(). THE DEVICE WAS EVALUATED BY BAXTER (B)(4). VISUAL INSPECTION: CORROSION WAS NOTED ON THE PRONGS OF THE AC POWER CORD DUE TO FLUID INTRUSION. THE FRONT PANEL WAS DENTED AND SCRATCHED OVER THE DISPLAY. THE PUMP WAS VERY DIRTY BY THE VOLUME KNOB, PUMP CHANNEL AND BACKING PLATE. THE AC PLUG WAS NOT BAXTER ISSUE BUT WAS HOSPITAL GRADE. THERE WAS NO VISUAL DAMAGE TO THE POWER CORD. AS SOON AS THE PUMP WAS PLUGGED INTO AC IT POWERED UP BY ITSELF, PASSED SELF-TEST. OPERATIONAL CHECKOUT TESTS WERE PERFORMED; BACKPLATE ALIGNMENT TEST, PRIMARY INFUSION TEST, DOOR OPEN ALARM TESTING, AIR ALARM TESTING, DOWNSTREAM OCCLUSION TESTING, UPSTREAM OCCLUSION TESTING, BATTERY CHECK, PANEL LOCK TEST, SAFETY CLAMP TEST AND ELECTRICAL SAFETY TESTS. PUMP FAILED BATTERY CHECK. WHEN PUMP WAS UNPLUGGED FROM AC, THE PUMP POWERED OFF AND WOULD NOT POWER UP ON DC. BATTERIES WERE (B)(4) BRAND AND WERE OLD AND DRIED UP. SMALL RED BATTERY WIRE WITH IN-LINE FUSE WAS DISCONNECTED. FAILED ELECTRICAL SAFETY TESTS, GROUND IMPEDANCE TOO HIGH. INTERNAL INSPECTION FOUND MASSIVE FLUID INGRESS ON THE INSIDE BOTTOM OF BOTH HOUSINGS. NO DAMAGE FOUND ON PUMP HEAD MODULE (PCB)'S OR PUMP HEAD. ALL GROUND WIRES WERE SECURE. THE SOFTWARE VERSION IN THIS PUMP IS: V1.71. THE ASSIGNABLE CAUSE: CUSTOMER'S REPORTED CONDITION WAS NOT CONFIRMED OR DUPLICATED. THE PUMP FAILED ELECTRICAL SAFETY TEST. BAXTER NO LONGER SUPPORTS THE FLO-GARD (B)(4) DEVICES. BAXTER NOTIFIED CUSTOMERS THAT SERVICE OF THESE DEVICES WOULD END AS OF (B)(6) 2000. THE DEVICE WAS RETURNED TO THE CUSTOMER PER THEIR REQUEST AND UNREPAIRED. THE FOLLOWING WARNING WAS ATTACHED TO THE DEVICE UPON RETURN TO THE CUSTOMER: WARNING. DO NOT USE. RETURNED UNREPAIRED. THIS DEVICE HAS NOT BEEN UPGRADED, REPAIRED OR FUNCTIONALLY TESTED AND SHOULD NOT BE PUT INTO CLINICAL USE WITHOUT BEING REPAIRED AND TESTED BY A QUALIFIED INDIVIDUAL. BAXTER HAS CONDUCTED A TREND REVIEW FROM (B)(6) 2009 THROUGH (B)(6) 2010 WHICH REVEALED TWO REPORTS OF ELECTRICAL SHOCK FROM THIS CUSTOMER AND ONE SIMILAR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED TO BE RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. SHOULD THE DEVICE BE EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A VETERINARY CLINIC MANAGER CALLED BAXTER PRODUCT SURVEILLANCE ON (B)(6) 2010 TO REPORT A FLO-GARD 6200 INFUSION PUMP WHICH HAD SHOCKED A TECHNICIAN AT THE FACILITY. DURING A FOLLOW UP CALL ON (B)(6) 2010 THE FOLLOWING INFORMATION WAS PROVIDED: THE TECHNICIAN INDICATED HE EXPERIENCED AN ELECTRICAL SHOCK ON (B)(6) 2010. REPORTEDLY HE WAS REACHING FOR THE PUMP AFTER A SURGICAL PROCEDURE, HAD ONE HAND ON THE POLE AND ONE HAND ON THE PUMP WHEN HE EXPERIENCED THE SHOCK. THE SHOCK CAUSED HIS ARM TO BECOME NUMB FOR A FEW SECONDS. THE TECHNICIAN INDICATED HIS HANDS WERE WET, BUT HE WAS NOT STANDING IN WATER, ALTHOUGH THE FLOOR MAY HAVE BEEN WET. NO INTERVENTION WAS REQUIRED AND HE HAS EXPERIENCED NO RESIDUAL EFFECTS. ADDITIONALLY, THE VETERINARY PHYSICIAN EXPERIENCED A SIMILAR SHOCK A FEW MINUTES LATER FROM THE SAME DEVICE, ON THE SAME DURING AND DURING THE SAME PROCEDURE. COMPLAINT NUMBER (B)(4) HAS BEEN OPENED TO ADDRESS THE 2ND REPORT OF ELECTRICAL SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6200 PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other