BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1866069 · Received October 12, 2010

    Report

    Report Number
    1423500-2010-04344
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE RECEIVED A RETURN CALL FROM THE HOME PATIENT. THE HOME PATIENT STATED THAT SHE WAS IN DWELL 2 AND WAS JUST ABOUT TO DOZE OFF TO SLEEP WHEN SHE HEARD A PLOP. THE HP NOTICED THAT THE FILL BAG FELL OFF OF THE TABLE AND LANDED IN A BOX OF HER EXTRA EXTENSION LINES. THE PATIENT STATED THAT SHE USED THE PROCEDURES THAT WERE TAUGHT TO HER IN THE CLINIC. SHE CLOSED THE TRANSFER SET AND CLAMPED OFF ALL OF THE BAGS AND THEN CALLED BAXTER FOR HOW TO CONTINUE HER THERAPY. THE PATIENT STATED THAT SHE COMPLETELY DISCONNECTED AND PERFORMED TWO EXCHANGES MANUALLY TO COMPLETE THERAPY FOR THE NIGHT. THE HP STATED THAT SHE DID NOT KNOW WHAT HAPPENED AS THE TABLE THAT SHE PUTS THE HC ON AND THE SUPPLIES IS VERY STURDY AND THERE IS PLENTY OF ROOM TO FIT EVERYTHING. THE HP STATED THAT SHE DID NOTICE THAT THE HEATER BAG WAS PULLING KIND OF HARD FROM THE FILL BAG. THE HP DID NOT HAVE A SAMPLE. THE HP STATED THAT THERE WAS NO INJURY OR MEDICAL INTERVENTION AND HAS BEEN ABLE TO CONTINUE THERAPY FINE. THIS COMPLAINT FOR A REPORT OF A CONNECTION ISSUE WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE DUE TO THE SUPPLY BAG FALLING AND DISCONNECTING. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. 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.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SUPPLY BAG THAT FELL AND DISCONNECTED DURING DWELL 2 OF 4 ON THE HOMECHOICE (HC) UNIT. THE HP STATED SHE PRESSED STOP; THE HP CONFIRMED THERE WAS NO ALARM OR AIR IN THE LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY. THE HP STATED SHE WOULD RESTART THERAPY WITH A NEW BAG AND CASSETTE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 50 YR