BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1873092 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04565
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT SAMPLE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A TOTAL OF 5 ACTUAL AND COMPANION SAMPLES WERE RETURNED FOR EVALUATION. THREE (3) TRANSFER SETS OF PRODUCT CODE 5C4483 = LOT H10F01037 AND ONE (1) OF PRODUCT CODE 5C4482 = LOT UNKNOWN WERE RECEIVED. ONE OF THE 5C4483 WAS A COMPANION SAMPLE AND NOT USED, WHILE THE OTHER 3 SAMPLES WERE ALL USED. THE THREE USED SAMPLES ALSO HAD THE BETA CAP CONNECTOR ATTACHED TO EACH TRANSFER SET (KENDAL BETA CAPS PRODUCT CODE 661001 = TO LOT 834225). THERE ALSO WAS AN UNUSED SAMPLE TRANSFER SET RETURNED OF THE PERITONEAL DIALYSIS (PD) BASIC TRANSFER SET WHICH IS AN APRON WITH TRANSFER SET AND BETA CAP ADAPTER IN PACKAGE. ALL PARTS WERE VISUALLY CHECKED FOR ANY DEFECTS. THE THREADING OF THE TRANSFER SET CONNECTOR WAS EXAMINED BY A MICROVUE WHICH IS LARGE MAGNIFICATION LIKE MICROSCOPE. PHOTOS WERE TAKEN AND SAMPLE 5C4482 LOT UNKNOWN SHOWED SOME DAMAGED THREADS. ALL OTHER SAMPLES HAD NO DEFECTS OR DAMAGES FOUND. THE TRANSFER SETS WERE TORQUED ONTO EACH CATHETER ADAPTER WITH A TORQUE GAUGE THAT HAS APPROPRIATE FIXTURE TO HOLD THE ADAPTER IN PLACE. THE GAP BETWEEN THE ENGAGEMENT OF THE ADAPTER AND THE TRANSFER SET CONNECTION WAS MEASURED ON EACH SAMPLE. A LEAK TEST WAS THEN PERFORMED ON ALL SAMPLES AND NO LEAKING WAS FOUND ON ANY OF THE SAMPLES. NO ISSUES WERE FOUND WITH THE CONNECTIONS AS ALL SAMPLES WERE ALL ENGAGED TOGETHER. A BATCH REVIEW OF THE 3 LOT NUMBERS OF TRANSFER SETS WAS PERFORMED WITH NO ISSUES. THE REPORTED ISSUE OF A LOOSE CONNECTION WAS NOT CONFIRMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A NURSE (RN) REPORTED A LOOSE CONNECTION BETWEEN THE TRANSFER SET AND PLASTIC BETA CAP ADAPTER. THE RN REPORTED THE PARTS DID NOT FIT. THE RN STATED SHE NOTED DIFFICULTY THREADING THE PRODUCTS TOGETHER AND FURTHER STATED ONCE THE PRODUCTS WERE TWISTED TOGETHER, THE CONNECTION WAS LOOSE. THE RN REPORTED SHE DID NOT USE ANY ASSISTIVE TOOLS TO MAKE THE CONNECTION; THE RN ALSO STATED SHE WORE GLOVES WHEN HANDLING THE PRODUCTS. THERE IS NO SPECIFIC PATIENT INVOLVEMENT; THE RN STATED THERE HAVE BEEN NO REPORTS OF PRODUCT SEPARATION WITH ANY PATIENTS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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

    Patients

    Seq Age Sex Outcome Treatment
    1