BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1800427 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02518
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 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). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AS IT HAS BEEN DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF A LEAK WITH SYSTEM ERROR 2240 (AIR IN LINE) ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE, THEREFORE, A ROOT CAUSE WAS NOT DETERMINED. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOTS (H10F10095) WITH NO ISSUES NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT RECEIVING SYSTEM ERROR 2240 WITH THE HOMECHOICE MACHINE DURING DRAIN 3 OF 3. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP). THE HP STATED THAT THERE WAS A LEAK SOMEWHERE ON THE PATIENT LINE BUT SHE COULD NOT FIND IT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S WIFE ON (B)(6) 2010. ACCORDING TO THE PATIENT'S WIFE THERE WAS A LEAK IN THE PATIENT LINE, HOWEVER, THEY DID NOT PIN POINT THE LEAK. THE WIFE STATED THAT THEY NOTIFIED THE NURSE AND SHE ADVISED THEM TO DISCARD SUPPLIES AND START OVER. THE PATIENT RESUMED THERAPY AND IS DOING FINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE. ADDITIONAL TEXT: POWER MODULE BEEPING ALARM WI YELLOW WRENCH & RED INT BATTERY ALARM. SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY. ADDITIONAL TEXT: OTHER COMPONENT: POWER MODULE. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF OTHER COMPONENT, SPECIFY. OTHER INTERVENTION : IMPLANT DEVICE TYPE: LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10F10095

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR