BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3082530 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10650
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO IMMEDIATELY PLACE THE MINICAP DISCONNECT CAP ON THE TRANSFER SET AFTER DISCONNECTING WHEN PERFORMING PERITONEAL DIALYSIS THERAPY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER REGARDING AN UNRELATED ALARM DURING USE. THE HOME PATIENT (HP) DISCONNECTED AND DID NOT CAP THE TRANSFER SET OFF. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP RECYCLE THE POWER TO CLEAR THE ALARM AND EXPLAINED THE ALARMS. THE HP WOULD DISCARD THE SUPPLIES AND FINISH WITH MANUALS. THE HP WOULD CALL THE REGISTERED NURSE REGARDING THE HP DISCONNECTING AND NOT CAPPING OFF. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183184 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE