BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1933441 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07071
    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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE INFORMATION OBTAINED BY BAXTER, THE CAUSE OF THE ERROR IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE PATIENT EXPLAINED THEY DISCONNECTED TO USE THE RESTROOM, RECONNECTED AND THEN RECEIVED THE ERROR. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H10G02025) WITH NO ISSUES NOTED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS THE PATIENTS ON HOW TO DISCONNECT FOR A SHORT TIME PERIOD. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR, AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED DESPITE THE LOT NUMBER BEING PROVIDED BY THE CUSTOMER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING A DRAIN CYCLE. THE PATIENT EXPLAINED THEY DISCONNECTED TO USE THE RESTROOM, RECONNECTED AND THEN RECEIVED THE ERROR. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR. GTS THEN ADVISED THE PATIENT TO DISCARD THE SUPPLIES AND FINISH THERAPY MANUALLY. PRODUCT SURVEILLANCE CONTACTED THE PATIENT REGARDING THE REPORTED EVENT. THE PATIENT STATED SHE DISCARDED THE SAMPLE, BUT PROVIDED THE LOT NUMBER. THE PATIENT STATED SHE NOTIFIED HER NURSE OF THE ALARM. THE PATIENT STATED SHE WAS ABLE RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES THE FOLLOWING DAY. NO INJURY OR MEDICAL INTERVENTION 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 H10G02025

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE PRO APD CYCLER (B)(4) (REFURBISHED)