BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1963131 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00751
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 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). THIS REPORT FOR A LOW DRAIN VOLUME ALARM (LDVA) THAT OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NO ROOT-CAUSE HAS BEEN DETERMINED. 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). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A LOW DRAIN VOLUME ALARM, THE CARE GIVER (CG) STATED THERE WAS AIR IN THE TUBE BETWEEN THE TRANSFER SET AND THE ABDOMEN. THE TSR RECOMMENDED THAT CG END THERAPY ON THE HC AND TRY DOING A MANUAL DRAIN (MANUAL SUPPLIES) TO SEE IF THE AIR DRAINS OUT, THEN CALL THE NURSE REGARDING THE AIR IN TRANSFER SET TUBING. THE TSR THEN WALKED CG THROUGH ENDING THERAPY ON THE HC. THE CG ENDED THERAPY, WILL DO A MANUAL DRAIN AND THEN FILL, THEN CG WILL CALL THE NURSE. A FOLLOW UP WAS DONE VIA PHONE CALL. THE RN STATED THE HOME PATIENT (HP) HAD INFORMED THEM ABOUT THE PROBLEM. THE HP WAS JUST IN THE CLINIC AND THERAPY WAS GOING WELL WITH NO COMPLAINTS. THERE WAS NO INJURY OR MEDICAL INTERVENTION WAS 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 84 YR HOME CHOICE CYCLER