BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2030102 · Received March 26, 2011

    Report

    Report Number
    1423500-2011-03716
    Event Type
    Malfunction
    Date Received
    March 26, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AS NO SAMPLES HAVE BEEN RECEIVED FOR ANALYSIS. A ROOT CAUSE WAS NOT DETERMINED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 2 ASSOCIATED WITH THIS COMPLAINT. THE DEVICE IS STILL IN USE AND THE LOT NUMBER IS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A SYSTEM ERROR (SE) 2317 ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING FILL 3 OF 4, THE HOME PATIENT (HP) REVEALED THAT THE TRANSFER SET CAME APART AND THAT THE HP HAD TRIED TO RECONNECT AND RESTART THERAPY, BUT THE HC MACHINE ALARM KEPT OCCURRING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CLEAR THE ALARM, ASSISTED TO DISCONNECT AND REMOVE CASSETTE, EXPLAINED THE ALARM AND POSSIBLE CAUSES AND ASSISTED TO END THERAPY. THE TSR ADVISED THE HP TO CONTACT NURSE ABOUT TRANSFER SET REPLACEMENT. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE NURSE, IT WAS REVEALED THAT THE SEPARATION OCCURRED BETWEEN THE TRANSFER AND THE TITANIUM ADAPTER, AS THE HP OVERSTRETCHED IT WHILE WALKING. THE NURSE CONFIRMED THAT HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP WAS GIVEN PROPHYLACTIC ANTIBIOTICS. PER NURSE, HP IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFER SET