BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1920354 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06773
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 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 SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DWELL WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE ANIMAL DAMAGED THE LINES. THE HOME PATIENT (HP) SAID SHE HAD MICE IN THE HOME AND THEY WERE BITING THRU THE LINES. THE HP CONFIRMED THE CAUSE OF THE ALARM WAS ANIMAL DAMAGE. THIS REVIEW FINDS THE TRAINING AND LABEL MATERIALS ADEQUATE RELATED TO THE USE/USER ERROR THAT OCCURRED THAT LED TO THE SYSTEM ERROR 2240. 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 HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DWELL. THE HOME PATIENT (HP) SAID SHE HAD MICE IN THE HOME AND THEY WERE BITING THRU THE LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM. A FOLLOW UP WAS MADE VIA PHONE CALL WITH THE HOME PATIENT (HP) REGARDING THE ALARM. THE HP CONFIRMED THE CAUSE OF THE ALARM WAS ANIMAL DAMAGE. THE HP STATED HE DISCARDED THE SAMPLE AND DID NOT KNOW THE LOT NUMBER. PER THE HP, SHE WAS GOING TO MOVE INTO A NURSING HOME UNTIL THE ISSUE WAS RESOLVED. THE HP EXPLAINED SHE DID NOTIFY HER NURSE OF THIS ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT.

    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