BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2821763 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04227
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMAIL RECEIVED ON (B)(6) 2012 FROM THE BAXTER REPRESENTATIVE REPORTING THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS WITH NO PATIENT SYMPTOMS. THE PATIENT WAS TREATED WITH VANCOMYCIN 2 G ONCE DAILY (ROUTE UNKNOWN). THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT BUT HAD HOME CARE NURSING. THIS COMPLAINT IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THERE WAS NO SAMPLE RETURNED TO BAXTER FOR EVALUATION. REVIEWS OF MANUFACTURING RECORDS REVEALED NO ISSUES AND NO DEVIATIONS FROM STANDARD PROCEDURE. NO ADVERSE TREND WAS IDENTIFIED FOR THIS MECHANISM. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR (B)(4) WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED NOR COULD AN ASSIGNABLE CAUSE BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A DISCONNECTION ISSUE BETWEEN A UV FLASH TRANSFER SET AND A TITANIUM ADAPTER THAT OCCURRED DURING USE. THIS REPORT ADDRESSES THE UV FLASH TRANSFER SET. THE DISCONNECTION HAPPENED WHEN THE PATIENT WAS AT HOME AND THE PATIENT RECONNECTED THE UV FLASH TRANSFER SET TO THE TITANIUM ADAPTER. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS,DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H11I23042

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention TITANIUM ADAPTER| PHYSIONEAL 40 1.36%