BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3772122 · Received April 25, 2014

    Report

    Report Number
    1416980-2014-13293
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE TRANSFER SET WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSFER SET SEPARATED FROM A TITANIUM ADAPTER WHILE THE HOME PATIENT (HP) WAS USING A HOMECHOICE (HC) DEVICE DURING DWELL FOUR OF FOUR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CAREGIVER (CG) TO END THERAPY AND WALKED THE CG THROUGH THE PROCEDURE. THE CG STATED THAT THE HOME PATIENT (HP) WAS GIVEN ANTIBIOTICS AS A PRECAUTIONARY MEASURE. DURING FOLLOW UP, THE REGISTERED NURSE (RN) STATED THAT THEY DID NOT SEE ANYTHING WRONG WITH THE TITANIUM ADAPTER OR THE TRANSFER SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251716 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE| LOCKING TITANIUM ADAPTER