BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1760295 · Received July 16, 2010

    Report

    Report Number
    1423500-2010-01521
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AN OVERPRIME IN THE PATIENT LINE THAT OCCURRED DURING PRIMING WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE PACEMAKER WOULD NOT INTERROGATE, A MESSAGE WAS DISPLAYED THAT KEPT REPEATING EVERY TIME OK WAS PRESSED. A MAGNET WAS APPLIED AND NO MAGNET RESPONSE WAS OBSERVED ALONG WITH NO PACING. THE DEVICE WAS EXPLANTED AND WAS REPLACED WITH A NEW ELA REPLY DEVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING AN OVERPRIME ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) REPORTED SHE WAS TRYING TO RE-PRIME MACHINE BUT WHEN SHE TURN IT ON THE DISPLAY MESSAGE WAS LAST FILL VOLUME. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD HP CYCLE MACHINE AND THEN PRESS GO. HP STATED THAT FLUID WAS COMING OUT OF THE PATIENT LINE. THE TSR ADVISED HP THAT THIS MEANT PATIENT LINE WAS PRIMED. PRODUCT SURVEILLANCE FOLLOWED UP (B)(6) 2010 WITH THE HP WHO STATED ALL SUPPLIES WERE DISCARDED AFTER USE. HP WAS NOT ABLE TO PROVIDE THE LOT NUMBER. THE HP DID NOT RECALL ANY SPECIFIC DETAILS FROM THIS EVENT. THE HP WAS ABLE TO CONTINUE WITH THE THERAPY AFTER SPEAKING WITH THE TSR. THE HP REPORTED SHE CONTINUES TO USE THE CYCLER AND WAS DOING VERY WELL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR