BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1982089 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01674
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    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. 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 THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 3 OF 4. THE HP FOUND THAT THE SUPPLY BAG WAS NOT COMPLETELY SPIKED. GTS HAD THE HP CYCLE POWER. THE HP WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, THE HP SAID, THE BAG WASN'T SPIKED ALL THE WAY AND THE LINE AND THE BAG BECAME SEPARATED. THE HP SAID THAT HE DID NOT KNOW WHAT MIGHT HAVE CAUSED THE SEPARATION, AND HE DID NOT NOTICE IT UNTIL AFTER THE ALARM. HE DID NOT SEE ANYTHING UNUSUAL WITH THE SUPPLIES. THE HP SAID THAT HE USED A COMPACT EXCHANGE DEVICE (CXD) TO SPIKE THE BAGS. THE HP SAID HE COULD NOT REMEMBER IF HE TOLD HIS NURSE ABOUT THE ALARM, BUT THAT EVERYTHING HAD BEEN GOING FINE SINCE. 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 74 YR HOMECHOICE CYCLER