BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1923691 · Received December 14, 2010

    Report

    Report Number
    1423500-2010-06857
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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. 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 THE INITIAL DRAIN. GTS HAD THE PATIENT CYCLE POWER TO THE "PRESS GO TO START" PROMPT. GTS THEN HAD THE PATIENT ARROW DOWN TO "CHANGE PROGRAM" AND PRESS "ENTER". GTS HAD THE PATIENT CHECK THE FILL VOLUME (2200ML) AND THE LAST FILL VOLUME (2200ML). GTS ASKED THE PATIENT HOW MUCH THEY DRAINED, AND THE PATIENT SAID 60ML. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. GTS THEN INSTRUCTED THE PATIENT TO START OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS NURSE. SHE EXPLAINED THAT SHE WAS NOT AWARE OF THE ERROR AND THAT TO HER KNOWLEDGE, THE PATIENT WAS DOING FINE. PRODUCT SURVEILLANCE ALSO CONTACTED THE PATIENT. THE PATIENT EXPLAINED THAT HE OPENED THE PATIENT LINE BY MISTAKE, SOME FLUID CAME OUT AND HE LOST THE PRIME. THE PATIENT STATED THAT HE DID NOT NOTIFY HIS DIALYSIS NURSE AS HE HAS DONE THIS BEFORE. THE PATIENT EXPLAINED THAT HE WAS AWARE OF THE PROPER PROCEDURES, BUT SOMETIMES FORGETS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)