BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2200998 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10559
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS TO BE RETURNED TO THE LOCAL BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. SHOULD AN EVALUATION BE PERFORMED OR ADDITIONAL INFORMATION RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RETURNED TO THE BAXTER LAB FOR EVALUATION. THIS COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. WE WERE UNABLE TO DUPLICATE THE COMPLAINT UNDER LAB CONDITIONS WITH THE RETURNED SAMPLE. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE RETURNED SAMPLE RETURNED DID NOT SHOW ANY CONNECTION PROBLEMS OR LEAKAGE. A BATCH REVIEW WAS PERFORMED FOR SAMPLE PROVIDED ( LOT NUMBER UNKNOWN) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    BAXTER (B)(6) RECEIVED A REPORT THAT A PATIENT'S ABDOMEN WAS PAINFUL 2 DAYS AFTER CHANGING THE TRANSFER SET IN THE HOSPITAL. THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED PERITONITIS. DURING CHECKING, THE NURSE FOUND THERE WAS A LEAK AT THE CONNECTION BETWEEN THE CATHETER CONNECTOR AND THE TITANIUM ADAPTER. AFTER CHANGING THE TRANSFER SET, NO LEAK WAS FOUND. REPORTEDLY, THE PATIENT DOUBTED THE PERITONITIS WAS DUE TO THE PRODUCT LEAKAGE. ADDITIONAL INFORMATION RECEIVED FROM BAXTER (B)(6) ON (B)(6) 2011 INDICATES: THIS IS A (B)(6) FEMALE PATIENT WHO WENT TO THE HOSPITAL DAILY FOR TREATMENT FROM (B)(6) 2011 TO (B)(6) 2011. THE TREATMENT INCLUDED CEFAZOLIN AND CEFTAZIDIME FOUR BAGS PER DAY FOR A TOTAL OF 14 DAYS OF TREATMENT. THE PATIENT HAD BEEN TRAINED AND HAS BEEN RETRAINED RELATED TO ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H11A31042

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention