BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3023445 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07432
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS UNAVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT ARE UNKNOWN; IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 ALARM AND WAS REPORTED THAT THE PATIENT PULLED THE TRANSFER SET APART, WHICH IS A USE ERROR THAT MAY CAUSE AIR TO ENTER THE DISPOSABLE TUBING AND CAUSE A SYSTEM ERROR 2240 ALARM. THE INSTRUCTIONS LISTED IN THE HOMECHOICE APD SYSTEM PATIENT AT-HOME GUIDE PROVIDES PROPER INSTRUCTIONS FOR THE CUSTOMER TO FOLLOW WHEN EXPERIENCING A SYSTEM ERROR 2240 ALARM. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING DRAIN 4 OF 6 ON THE HOME CHOICE (HC). THE CAREGIVER (CG) STATED THE PART OF THE CATHETER THAT THE PERITONEAL DIALYSIS (PD) FACILITY REPLACED CAME LOOSE DURING DRAIN 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CG TO CYCLE THE POWER, END THERAPY, AND ADVISED TO CONTACT THE PERITONEAL DIALYSIS NURSE (PDRN). THE CG WOULD CALL IN THE MORNING. PRODUCT SURVEILLANCE SPOKE WITH THE PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE SYSTEM ERROR 2240. PER THE PDN, THE HOME PATIENT (HP) HAD A PROBLEM WITH HER TRANSFER SET AND NOT THE CATHETER. THE PDN STATED THAT THE HP PULLED THE TRANSFER SET APART. THE PDN STATED THE HP CAME INTO THE CLINIC AND THEY CHANGED OUT THE TRANSFER SET. THE OLD SET WAS DISCARDED. THE PDN STATED THERE WAS NO MALFUNCTION WITH THE TRANSFER SET. THE HP RESUMED THERAPY WITHOUT PROBLEMS AND WAS DOING WELL. NO FURTHER INFORMATION WAS GIVEN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126332 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE.