BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1802129 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02471
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 25, 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 ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION THE MOST LIKELY CAUSE OF THE LOW DRAIN VOLUME ALARM IS THE AIR IN THE PATIENT LINE. LABEL REVIEW WAS ADEQUATE FOR THE POTENTIAL USE ERROR IN THE COMPLAINT. . BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE OF THE REPORTED PROBLEM OF AIR IN THE LINE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA NUMBER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLOSED CLIP CAME OUT AND THE CLIP COULD NOT BE FED INTO THE JAW. THE DEVICE COULD NOT BE FIRED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC)DEVICE DURING THE INITIAL DRAIN. THE HOMEPATIENT (HP) STATED THAT THERE WAS AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR)RECOMMENDED THAT THE HP END THERAPY AND START OVER WITH NEW SUPPLIES. FOLLOW UP WITH THE PATIENT REVEALED THAT HE DISCARDED THE SAMPLE AND DOES NOT RECALL THE LOT NUMBER. THE PATIENT STATED THAT HE IS DOING WELL AND CONTINUING WITH THERAPY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY/FKX FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR