BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1904868 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05968
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 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). THIS COMPLAINT FROM A PATIENT WHO NOTED A LEAK AROUND RED CLAMP DURING USE WAS NOT CONFIRMED AND NO ROOT CAUSE WAS DETERMINED BECAUSE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FROM A PATIENT WHO NOTED A LEAK AROUND RED CLAMP DURING USE WAS NOT CONFIRMED AND NO ROOT CAUSE WAS DETERMINED BECAUSE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A LABELING REVIEW WAS CONDUCTED AND THE LABELING WAS FOUND ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING CUSTOMER FOLLOW UP FOR ANOTHER EVENT, A HOME PATIENT (HP) REPORTED THAT WHEN HE WENT TO CLOSE THE RED CLAMP THE PLASTIC TUBING WAS WET AND SO WAS HIS CARPET. HE DID NOT KNOW IF THE LIQUID CAME FROM THE CASSETTE (B)(4). THE HP STATED HE WAS USING A GREEN BAG AT THE TIME. THE HP STATED THAT HE WAS HAVING BACK TROUBLE AND COULD NOT CHECK TO SEE IF THEY STILL HAD THE CASSETTE AND BAGS AVAILABLE. THE HP STATED HIS WIFE WOULD BE HOME LATER THIS AFTERNOON AND SHE SHOULD HAVE MORE INFORMATION SINCE SHE HOOKS HIM UP FOR THERAPY.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED THROUGH THE (B)(4) THROUGH BAXTER'S AFTER HOURS CALL SERVICE. IT WAS REPORTED THAT THE HOMECHOICE MACHINE SOUNDED A 2240 ALARM (AIR IN SET) DURING INITIAL DRAIN. THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE ALARM AND DIDN'T DISCONNECT AT ANY TIME PRIOR TO THE ALARM. ALL BAGS WERE PROPERLY SPIKED AND CONNECTED. NO PATIENT EXTENSION LINES WERE USED. THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. NOTHING UNUSUAL WAS NOTED ABOUT THE SUPPLIES. THE PATIENT STATED THAT THEY WILL START WITH NEW SUPPLIES IN THE MORNING AND CALL THE RENAL NURSE IN THE MORNING. NO CLINICAL CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10H04060

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR