BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2160113 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-08989
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS FOR THE TRANSFER SET. SEE REPORT NUMBER 1423500-2011-08973 FOR THE REPORT ON THE MINICAP. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE, THE PRODUCT CODE IS UNKNOWN AT THIS TIME. THE SAMPLE IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE ROOT CAUSE WAS UNDETERMINED. THE CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) TO REPORT THE CATHETER CAP COMING OFF. THE HP STATED, HE WAS LYING IN BED AND NOTICED THE CAP OF HIS CATHETER HAD COME OFF AND WANTED TO KNOW WHAT TO DO. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED HP TO CONTACT HIS NURSE FOR INSTRUCTIONS. THE HP WOULD CALL HIS NURSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT. IT WAS CLARIFIED THAT IN FACT THE CAP CAME APART FROM THE TRANSFER SET AND NOT THE CATHETER AS ORIGINALLY REPORTED. THE HP WAS UNSURE WHY THE MINICAP CAME OFF THE TRANSFER SET. THE HP PLACED A NEW MINICAP ON THE TRANSFER SET AND SAW HIS NURSE THE NEXT DAY. THE NURSE PUT ON A NEW TRANSFER SET AND THE HP HAS BEEN CONTINUING THERAPY WITH NO FURTHER ISSUES. ALL SUPPLIES HAVE BEEN DISCARDED AND THE LOT NUMBERS ARE UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 51 YR HOMECHOICE