BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1912516 · Received December 2, 2010

    Report

    Report Number
    1423500-2010-06441
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CHECK PATIENT LINE ALARM WAS NOT CONFIRMED DUE TO A LACK OF A SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER 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 INVESTIGATION IS IN PROGRESS.

    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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK PATIENT LINE ALARM IN FILL 1 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED HE FORGOT TO OPEN THE PATIENT CLAMP DURING THE PRIMING AND NOW HE THOUGHT HE HAD A LOT OF AIR INSIDE OF HIM. THE PATIENT LINE HAD A LOT OF AIR BUBBLES IN IT. THE HP STATED HE NEEDED TO END THERAPY TO START OVER WITH NEW SUPPLIES. THE TSR ASSISTED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2010 REGARDING THE ALARM. THE HP STATED THAT HE FORGOT TO OPEN THE CLAMP. HE DID INDICATE THAT HIS SUPPLIES WERE FINE, HOWEVER, HE DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW ONES. THE HP DOES NOT RECALL THE LOT NUMBER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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