BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2883720 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07938
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A LEAK WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE REGISTERED NURSE (RN) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING THE HOME PATIENT (HP) THINKING THAT THE MACHINE WAS NOT WORKING PROPERLY, WHICH OCCURRED ON THE HOMECHOICE (HC) AFTER USE. DURING TROUBLESHOOTING, THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE RN IF THE HP WAS AVAILABLE. THE RN STATED YES. THE RN GAVE THE HP'S PHONE NUMBER AND THE TSR CALLED THE HP. DURING TROUBLESHOOTING ABOUT THE HC ISSUES, THE HP ALSO STATED THAT HIS TRANSFER SET HAD HAD A LEAK ON AN UNSPECIFIED DATE AND THAT IT HAD BEEN REPAIRED. THE TSR ASKED THE HP IF THE TRANSFER SET WAS REPLACED. THE HP STATED HE WAS NOT SURE, HE JUST KNEW THAT HIS NURSES HAD REPAIRED IT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2012. SHE STATED THAT THE LEAK HAD OCCURRED FROM THE TRANSFER SET BECAUSE THE MINICAP HAD FALLEN OFF DUE TO THE PATIENT NOT PROPERLY TIGHTENING THE CAP ON THE TRANSFER SET. THE PATIENT DID NOT KNOW AT WHAT POINT THE CAP HAD FALLEN OFF AND ONLY NOTICED IT WHEN HE DISCOVERED THE LEAK. THE CLINIC HAD CHANGED THE TRANSFER SET OUT AND ADMINISTERED ANTIBIOTICS, BOTH AS A PREVENTATIVE MEASURES. SHE STATED THAT THERE WAS NOTHING UNUSUAL ABOUT EITHER THE CAP OR THE TRANSFER SET, NO DIFFICULTIES REPORTED WITH EITHER, AND NO ALLEGATIONS WERE MADE AGAINST ANY OF BAXTER'S PRODUCTS. THE DATE OF THE EVENT COULD NOT BE SPECIFIED. THERAPY SINCE HAS BEEN GOING WELL. SHE STATED THAT THE PATIENT HAS BEEN IN THE HOSPITAL DUE TO A FALL, BUT THE FALL INCIDENT WAS NOT RELATED TO PERITONEAL DIALYSIS OR ANY OF BAXTER'S PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE