BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1933420 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07072
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION BY BAXTER, THE PATIENT DISCONNECTED THE DEVICE FROM THE ELECTRICAL SERVICE OUTLET AND DID NOT COMPROMISE THE INTEGRITY OF THE DISPOSABLES. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING THERAPY QUESTIONS ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED THAT THE HC WAS SHOWING DWELL 1 OF 4 AND HE WANTED TO KNOW IF IT WAS STUCK. THE HP HAD UNPLUGGED THE HC TO GO TO THE BATHROOM. THE HP STATED THAT HIS NURSE SAID TO THAT THEY SHOULD UNPLUG IF HE HAD TO DISCONNECT. GTS ALSO ADVISED THE HP TO JUST PRESS STOP IF HE NEEDED TO DISCONNECT AND NOT UNPLUG THE HC DURING THERAPY. FOLLOW UP WITH THE NURSE REVEALED THAT THE HP MISUNDERSTOOD THEIR INSTRUCTIONS MOVING THE HC TO ANOTHER ROOM. THE NURSE SAID THAT THE HP'S THERAPY WAS GOING GREAT. THE NURSE STATED SHE WAS GOING TO CALL THE HP TO CLARIFY THE PROPER DISCONNECT PROCEDURES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR HOMECHOICE