BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1668198 · Received April 27, 2010

    Report

    Report Number
    1423500-2010-00606
    Event Type
    Malfunction
    Date Received
    April 27, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) TO REPORT THAT THE PATIENT LINE CONNECTOR DID NOT FIT THE PATIENT'S TRANSFER SET. THE HOME PATIENT (HP) STATED SHE JUST GOT OUT OF THE HOSPITAL AND THE END OF HER TRANSFER SET HAD A DIFFERENT CONNECTOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CALL THE PERITONEAL DIALYSIS NURSE (PDRN). ON (B)(4) 2010 PRODUCT SURVEILLANCE CONTACTED THE HP'S NURSE WHO STATED THAT THE TRANSFER SET HAD A LEAK; THE RN CONFIRMED THERE WAS NO PROBLEM WITH THE CONNECTOR. THE RN STATED WHEN THE MINICAP WAS REMOVED, A LEAK OCCURRED FROM THE BLUE PART. THE RN CONFIRMED THE PATIENT HAD JUST RETURNED HOME FROM THE HOSPITAL THAT MORNING AND THEN RETURNED TO THE CLINIC THAT AFTERNOON FOR A NEW TRANSFER SET. THE RN STATED THE TRANSFER SET WAS IN USE FOR APPROXIMATELY 4 WEEKS. THE RN STATED THE PATIENT HAD BEEN PERFORMING AMBULATORY PERITONEAL DIALYSIS (APD) SINCE (B)(6) 2008. THE RN STATED THE TRANSFER SET WAS NORMALLY TAPED TO THE PATIENT AND WAS CLEANED WITH SOAP AND WATER. THE RN ADVISED SHE WAS NOT AWARE OF OVERTORQUING OF THE TWIST CLAMP AS THE PATIENT WAS JUST DISCHARGED FROM THE HOSPITAL. THE RN CONFIRMED THAT SHE DISCOVERED THE LEAK WHEN THE MINICAP WAS REMOVED. THE RN STATED THERE WERE NO PROBLEMS REPORTED WITH OPENING OR CLOSING THE TWIST CLAMP. THE RN CONFIRMED THE HOME PATIENT HAD BEEN ASSISTED BY HOSPITAL STAFF AND SHE WAS NOT AWARE OF ANY EXCESSIVE FORCE/EXPOSURE TO THE SET BEFORE NOTICING THE LEAK. THE RN STATED SHE HAD DISCARDED THE SAMPLE AND DID NOT HAVE THE LOT NUMBER. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 37 YR