BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1894326 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05531
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED; LOT INFORMATION IS UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR A RELATED COMPLAINT FILE, THE CARE GIVER (CG) REPORTED TO PRODUCT SURVEILLANCE THAT SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE ; HOWEVER, DID NOTE THAT SOLUTION LEAKED OUT OF THE TOP OF THE PATIENT LINE. THE CG CONFIRMED THERE WAS NO LEAK IN THE CASSETTE. THE CG STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THE CG REPORTED NO ADVERSE EVENT RESULTING FROM THIS INCIDENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT. THE HP STATED SHE HAD ALREADY DISCONNECTED AND WAS READY TO SETUP AGAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAD ENTERED SETUP. THE HP CONFIRMED SHE WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED FOR ANY REASON. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THE HP CONFIRMED SHE WOULD CONTINUE THERAPY WITH NEW SUPPLIES. THERE WAS NO INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 51 YR