BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1894170 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05512
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DRAIN 1 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERRORS IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED SHE CONTACTED HER NURSE TO REPORT THE ISSUE AND STATED THAT HER NURSE RETRAINED HER ON PROPER PROCEDURES. THE HP CONFIRMED SHE WAS DOING WELL WITH THERAPY AND NO ADVERSE EVENT RESULTED FROM THIS INCIDENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 ALARM ON THE HOMECHOICE (HC) UNIT DURING DRAIN 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP STATED SHE DISCONNECTED PRIOR TO THE ALARM FOR 15 MINUTES AND WAS UNSURE IF THE DRAIN HAD STARTED WHEN SHE RECONNECTED TO THE MACHINE. THE TSR HAD THE HP CYCLE POWER TO DISPLAY PRESS GO TO START. THE HP CONFIRMED TO RESTART WITH NEW SUPPLIES. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED SHE CONTACTED HER NURSE TO REPORT THE ISSUE AND STATED THAT HER NURSE RETRAINED HER ON PROPER PROCEDURES. THE HP CONFIRMED SHE WAS DOING WELL WITH THERAPY AND NO ADVERSE EVENT RESULTED FROM THIS INCIDENT.

    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