BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3083026 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10677
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 6, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    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. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER REGARDING AN UNRELATED ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING USE. THE CARE GIVER (CG) STATED THAT THE HOME PATIENT (HP) DISCONNECTED FROM THE HC AND WHEN SHE WENT TO WASH HER HANDS, PART OF THE TRANSFER SET BROKE OFF. THE CG STATED THAT THEY FINALLY GOT THE TRANSFER SET REPAIRED BUT THE HP COULD NOT DO THERAPY THE PREVIOUS NIGHT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG IN ENDING THE CURRENT THERAPY. THE TSR ADVISED THE HP TO CONTACT HER RN. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) REGARDING THE DAMAGED TRANSFER SET. THE RN STATED THAT THE TRANSFER SET WAS NOT DAMAGED. THE RN STATED THAT THE TRANSFER SET BECAME DISCONNECTED FROM THE CATHETER. THE RN STATED THAT AFTER THE HP HAD FINISHED THERAPY THE HP NOTICED THAT THE TRANSFER SET HAD BECOME DISCONNECTED FROM THE CATHETER. THE RN STATED THAT THERE WAS NO VISIBLE DAMAGE AND SHE WAS NOT SURE WHY THEY BECAME SEPARATED. THE RN STATED THAT THE TRANSFER SET WAS REPLACED AND THE HP WAS ABLE TO CONTINUE THERAPY AT A LATER TIME. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185241 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR HOMECHOICE