BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1842390 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03644
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 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). THE ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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).

    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 DURING A PREVIOUS THERAPY IN DWELL 3 OF 4. THE HOME PATIENT (HP) FOLLOWED THE DIRECTIONS IN THE PATIENT MANUAL TO END THERAPY AND DISPOSED ALL OF THE SUPPLIES. THE HP DID NOT DISCONNECT AND DID NOT OBSERVE ANY LEAKS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARM AND ADVISED THE HP NOTIFY THE NURSE OF THE ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    CALLER REPORTED A FALSE NEGATIVE URINE HCG RESULT ON CONSULT DIAGNOSTIC HCG CASSETTE VS. SERUM QUANTITATIVE TEST RESULT (NO VALUE PROVIDED). CALLER SAID THE CUSTOMER HAD NOTICED TEST WAS NEGATIVE AT THE THREE MINUTE READ TIME, BUT WAS FAINT POSITIVE AT FIVE MINUTES. THE PT WAS IN FOR A PRE-PROCEDURAL CHECK PRIOR TO GETTING AN IUD. THERE WAS ANOTHER PT THAT HAD A FALSE POSITIVE, BUT NO DETAILS WERE PROVIDED OTHER THAN SHE WAS CONFIRMED POSITIVE BY SERUM QUANTITATIVE TEST.

    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