BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1893548 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05479
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 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 IS FOR A REPORT OF A PATIENT CONTAMINATING THE SUPPLY LINE TUBING WHILE SPIKING A SUPPLY BAG. THE PATIENT STATED THAT THE TUBING HIT THE WALL. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. NOT ENOUGH DATA ARE AVAILABLE WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING ASSISTANCE ENDING THERAPY ON THE HOME CHOICE (HC) DURING SET UP. THE HOME PATIENT (HP) STATED THAT HE CONTAMINATED ONE OF THE LINES AND NEEDED TO START OVER WITH NEW SUPPLIES. GTS ASSISTED WITH STOPPING SETUP. ON (B)(6) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE NURSE REGARDING THE "CONTAMINATED" SETUP. THE NURSE STATED THAT THE PATIENT HAS BEEN IN THE CLINIC SINCE THE INCIDENT AND IS CONTINUING WITH THERAPY WITHOUT ANY REPORTED PROBLEMS. THE NURSE VERIFIED THAT THERE WERE NO INFECTIONS, MEDICAL INTERVENTION OR PATIENT INJURY ASSOCIATED WITH THIS REPORT. ON (B)(6) 2010, THE HOMEPATIENT CALLED BACK AND HE SAID THAT WHEN HE WAS SPIKING HIS BAGS, THE TUBING HIT THE WALL AND HE CONSIDERED THE SUPPLIES TO BE CONTAMINATED. THE HOMEPATIENT DISCARDED THE SUPPLIES AND STARTED WITH NEW SUPPLIES. THE PATIENT DOES NOT RECALL THE LOT NUMBER.

    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 54 YR