BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2961485 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03760
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A REGISTERED NURSE (RN) CONTACTED BAXTER'S SERVICE CENTER REGARDING ONE OF HER PATIENTS DISCONNECTING HER TRANSFER SET WHICH OCCURRED ON THE HOMECHOICE (HC) WHILE TROUBLESHOOTING AN ALARM DURING FILL 5 OF 12. THE RN STATED THAT THE TERMINOLOGY "CLOSE AND REOPEN THE TRANSFER SET" HAD CONFUSED THE CARE GIVER (CG), AND THE CG HAD DISCONNECTED THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON. SHE STATED THAT THE CARE GIVER (CG) THOUGHT THAT SHE WAS BEING TOLD TO DISCONNECT THE TRANSFER SET, AND ASKED THE TSR IF SHE SHOULD USE MASK, GLOVES, AND WASH HER HANDS. THE PATIENT THEN DISCONNECTED THE TRANSFER SET AND IT LEAKED. THE PATIENT RECONNECTED THE TRANSFER SET. THE CG HAD BROUGHT THE HP INTO THE CLINIC, AND THE CLINIC CHANGED OUT THE TRANSFER SET AND ADMINISTERED ANTIBIOTICS PREVENTATIVELY. THE CLINIC HAS BEEN MONITORING THE HP, AND SO FAR ALL RESULTS HAVE BEEN NORMAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER PRODUCT SURVEILLANCE CONTACTED THE CARE GIVER. SHE CONFIRMED THAT SHE DISINFECTED THE AREA AND USED GLOVES AND A MASK. SHE STATED THAT THE PATIENT HAS BEEN GOING WELL SINCE, AND THE CELL CULTURES HAVE SHOWN NO GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64795 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO HOMECHOICE