BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3900755 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20768
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACTUAL OCCURRENCE DATE AND THE THERAPY DATE IS UNKNOWN. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CRACK ON THE LIGHT BLUE PORTION OF THE TRANSFER SET. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE TWIST CLAMP WAS CRACKED. THE PDRN STATED THAT THE CRACK ON THE TRANSFER SET WAS DUE TO THE HOME PATIENT (HP) NOT SECURING THE SET PROPERLY. THE PDRN STATED THAT THE HP HAD LEFT THE TRANSFER SET DANGLING UNSECURED AND IT SLAMMED AGAINST THE SINK WHICH CRACKED THE SET. THE PDRN STATED THAT THE HP DID NOT USE ANY TOOLS TO OPEN OR CLOSE THE TWIST CLAMP. THE TRANSFER SET WAS CHANGED OUT DUE TO THE DAMAGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377219 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 DIANEAL 1.5%, 2.5% AND 4.25% PD4 AMBUFLEX| HOMECHOICE