BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1913883 · Received December 3, 2010

    Report

    Report Number
    1423500-2010-06481
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. THE PRODUCT SAMPLE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A SYSTEM ERROR (SE) 2240 ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT MULTIPLE ALARMS THAT OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING PRIMING. THE HP FURTHER STATED HE REVIEWED THE ALARM LOG AND NOTED SYSTEM ERROR (S/E) 2240 OCCURRED. THE HP STATED THAT HE USED THE SAME CASSETTE AFTER RELOADING IT AND THEN GOT REPEATED ALARMS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED THE SET UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2010 (B)(4) PRODUCT SURVEILLANCE CONTACTED THE HP WHO REPORTED NO FURTHER ISSUES.

    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 H10H23102

    Patients

    Seq Age Sex Outcome Treatment
    1