BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1891907 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05370
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 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 FOR PROBLEM CODE CONNECTION ISSUE IS NOT CONFIRMED DUE TO LACK OF SAMPLE. ROOT CAUSE IS UNDETERMINED DUE TO LACK OF SAMPLE. 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). THE REPORTED CONDITION WAS RESOLVED OVER THE PHONE; THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A CHECK LINES AND BAGS ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING PRIME. THE HP STATED WHEN SHE WAS CHECKING THE LINES AND BAGS ONE OF THE SPIKES DISCONNECTED FROM THE BAG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER USING NEW SUPPLIES. THE TSR FURTHER ASSISTED THE HP TO CLOSE ALL CLAMPS AND CYCLE POWER OFF/ON. THE HP CONFIRMED THE CASSETTE WAS REMOVED. THE HP CONFIRMED SHE WAS NOT CONNECTED TO THE HC: THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THIS EVENT WAS AN ISOLATED INCIDENT. THE HP CONFIRMED SHE USES A COMPACT EXCHANGE DEVICE (CXD) TO ASSIST HER WITH SPIKING HER BAGS. THE HP STATED THIS PARTICULAR NIGHT WAS THE ONLY TIME SHE HAS HAD ANY ISSUES. THE HP CONFIRMED SHE RESUMED THERAPY WITHOUT INCIDENT OR ADVERSE EVENT.

    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