BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1980777 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01580
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    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 AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DWELL 4/7 WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE OF THE LOOSE CONNECTION OF THE SUPPLY BAG. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H10I25055) WITH NO ISSUES NOTED. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THERAPY, IN DWELL CYCLE 4 OF 7. (B)(4) EXPLAINED THE SYSTEM ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER. THE PATIENT STATED THAT IN DWELL 1, HE NOTICED A CONNECTION ON THE SUPPLY BAG WAS LOOSE AND SOLUTION WAS COMING OUT OF THE BAG. THE PATIENT STATED HE TIGHTENED THE CONNECTION AND CONTINUED THERAPY. (B)(4) ADVISED WHEN SOLUTION LEAKED OUT OF THE BAG DURING THERAPY, THE PATIENT WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE PATIENT THEN STATED THERE WAS AIR IN THE LINES. (B)(4) ASSISTED THE PATIENT IN DISCONNECTING. THE PATIENT ELECTED TO COMPLETE THERAPY WITH MANUAL SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED HE DID NOT KNOW WHY THE CONNECTION WAS LOOSE. THE PATIENT DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE PATIENT STATED HE SPOKE WITH HIS NURSE THE NEXT DAY, AND WAS ABLE TO PROVIDE THE LOT NUMBER. THE PATIENT STATED HE WAS ABLE TO COMPLETE THERAPY AND THAT EVERYTHING HAD BEEN FINE SINCE. NO INJURY OR MEDICAL INTERVENTION WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)