BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1936303 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07171
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 27, 2010
    Report Date
    December 2, 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 REPORT IS FOR A CHECK LINES AND BAGS (CLB) ALARM. THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION THEREFORE COMPLAINT CANNOT BE CONFIRMED IN THE LAB. PER THE REPORT, THE PATIENT HAD THE DRAIN LINE SUBMERGED IN THE DRAIN RECEPTACLE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A CHECK LINES AND BAGS ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING PRIME. GTS HAD THE HOME PATIENT (HP) CHECK THE DRAIN LINE. THE HP STATED THAT THE DRAIN LINE WAS TOUCHING THE LIQUID IN THE TOILET, BUT SHE LIFTED IT OUT OF THE LIQUID. GTS EXPLAINED THAT THE HP WOULD HAVE TO START OVER WITH ALL NEW SUPPLIES. A FOLLOW UP WAS DONE VIA PHONE; ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION ON WHAT THE HP MEANT BY THE HEATER BAG DRAINING INTO THE SUPPLY BAG, BUT THE HP DID NOT RECALL/ COULD NOT EXPLAIN WHAT SHE MEANT. SHE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES AND COULD NOT THINK OF ANY REASON THE ALARM OCCURRED. THE LOT NUMBER WAS UNKNOWN AND NO SAMPLE WAS AVAILABLE. THE HP WAS UNSURE HOW LONG THE TRAIN LINE WAS TOUCHING THE WATER IN THE TOILET. 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 PD CYCLER