BEUDAMED
    FDA Adverse Event Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1930931 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06985
    Date Received
    December 16, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS CONFIRMED IN THE LAB DUE TO THE CRACK. ONE USED SET WAS RECEIVED WITH CAP ON DARK BLUE CONNECTOR AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO CONNECTION ISSUE. DURING VISUAL INSPECTION OF THE SET CHIPPING/FLAKING AND CRACK OF THE LIGHT BLUE MAIN BODY WAS NOTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A ROOT CAUSE WAS NOT IDENTIFIED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER SWEDEN TO REPORT FROM A HOSPITAL REPORTING THAT THE BLUE PART OF THE MINICAP EXTENDED LIFE PD TRANSFER SET CLOSURE PART HAD EXPLODED. THE PATIENT PUT ON A CLAMP AND A IODINE CAP. ON SOME OCCASIONS THE PATIENT HAD USED SOME KIND OF TONGS TO BE ABLE TO CLOSE THE MINICAP TRANSFER SET, BECAUSE THE PATIENT REPORTEDLY HAD EXPERIENCED DIFFICULTIES TO CLOSE WHEN THE SET WAS NEW. THE PATIENT REPORTED THIS WHEN HE VISITED THE HOSPITAL. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H09F15030

    Patients

    Seq Age Sex Outcome Treatment
    1