BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1821865 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03031
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE OF THE SYSTEM ERROR 2240 ALARM WAS UNDETERMINED. 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)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM (AIR IN LINE), WHICH OCCURRED ON THE HOMECHOICE (HC) LAST NIGHT DURING DWELL 2. THE HOME PATIENT (HP) DISCARDED THE CASSETTE AND BAGS FROM LAST NIGHT. THE HP STATED SHE SPOKE WITH THE PERITONEAL DIALYSIS NURSE TODAY AND THE NURSE INSTRUCTED THE HP TO CALL BAXTER. THE HP HAD ENDED THERAPY AND PERFORMED A MANUAL DRAIN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE SPOKE TO THE PERITONEAL DIALYSIS (PD) NURSE. THE PD NURSE STATED THE HP BROUGHT THE HOMECHOICE DEVICE TO THE CLINIC AND ASKED HER TO FIX IT. THE PD NURSE INSTRUCTED THE HP TO CONTACT BAXTER REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE PD NURSE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE PD NURSE DID NOT KNOW THE CAUSE OF THE ALARM. THE HP IS CONTINUING THERAPY ON THE CYCLER AS USUAL.

    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 60 YR