BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1892653 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05444
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 16, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. 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 SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING SYSTEM ERROR 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DWELL 3 OF 4. THE HOME PATIENT (HP) WAS STILL CONNECTED AND THE SUPPLY BAGS WERE EMPTY AND THERE WAS SOLUTION IN ONLY THE HEATER BAG. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF ANY OF HIS BAGS HAD COME UNDONE, AND PER THE HP, THEY DID NOT. THE TSR ALSO EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR IT. AFTER THE ALARM WAS CLEARED THE HP COMPLETED HIS THERAPY WITH A MANUAL BAG. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. CORPORATE PRODUCT SURVEILLANCE SPOKE WITH THE HP ON (B)(6) 2010. THE HP STATED THAT EVERYTHING WAS GOING WELL FOR HIM AT THIS TIME. HE EXPLAINED THAT THE TSR WALKED HIM THROUGH ON SOLVING THE ALARM/ISSUE AT THE TIME AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE HP THANKED US FOR FOLLOWING UP AND STATED THAT HE WAS HAVING NO PROBLEMS AT ALL WITH THE HC.

    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