BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1920243 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06752
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 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. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. 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).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 ALARM (INDICATING AIR) THAT APPEARED ON THE HOME CHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED SHE HAD DISCONNECTED TO USE THE BATHROOM BUT DID NOT PRESS STOP ON THE MACHINE AND SHE RECONNECTED WHEN THE ALARM OCCURRED. GLOBAL TECHNICAL SERVICES (GTS) HAD THE HP DISCONNECT AND REMOVE THE CASSETTE TO DISCARD THE SUPPLIES. FOLLOW UP WITH THE NURSE REVEALED THAT SHE WAS AWARE OF THE ALARM. THE HP DID NOT EXPERIENCE ANY INJURY OR MEDICAL INTERVENTION. THE NURSE STATED THAT THEY CLARIFIED PROPER PROCEDURES WITH THE HP. THE NURSE STATED THAT THE HP CONTINUED THERAPY THAT NIGHT WITH MANUAL SUPPLIES.

    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 59 YR