BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1880183 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04787
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 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 CONNECTION ISSUE IN WHICH THE SUPPLY BAG DISCONNECTED. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE SEPARATION IS DUE TO THE SUPPLY BAG FALLING AND SUBSEQUENTLY DISCONNECTING. IN A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE, THE NURSE STATED SHE DISCUSSED WITH THE PATIENT THE APPROPRIATE SETUP OF THE BAGS ON THE TABLE. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE IS DISCARDED AFTER THERAPY AND THE LOT NUMBER WAS 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

    PT REVISED FOR DISLOCATION. SALES REP MADE AWARE OF THIS EVENT ON (B)(4) 2010.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH ENDING THERAPY WHILE USING THE HOMECHOICE (HC). THE PATIENT STATED ONE OF THE SUPPLY BAGS FELL AND DISCONNECTED. THE PATIENT STATED SHE CALLED HER NURSE, WHO TOLD THE PATIENT TO END THERAPY FOR THE NIGHT AND TO SEE HER THE FOLLOWING DAY. THE PATIENT HAD STARTED THE ENDING THERAPY PROCEDURE BUT HAD NOT COMPLETED IT. GTS WALKED THE PATIENT THROUGH THE REST OF THE PROCEDURE AND CASSETTE REMOVAL. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP WITH THE NURSE REGARDING THE BAG FALLING AND DISCONNECTING, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND THAT SHE HAD DISCUSSED THE APPROPRIATE SETUP OF THE BAGS. PER NURSE, HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE NURSE STATED THAT THE HP DID NOT REPORT ANY DEFECTS ON THE SUPPLIES. PER NURSE, THE 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 INTEGRATED APD SET W/CASSETTE3-PRONG SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR