BEUDAMED
    FDA Adverse Event Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2141681 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08408
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION WAS PERFORMED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE (B)(4) CALL CENTER RECEIVED INFORMATION THAT THE PATIENT WAS HOSPITALIZED DUE TO PERITONITIS. THE PATIENT USED THE UV TRANSFER-SET (LOT NUMBER UNKNOWN) AND CLEAN FLASH. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL PD4 2.5 AND EXTRANEAL THERAPY. ON (B)(6) 2011, THE PATIENT CONTACTED THE BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT SHE HAD BEEN ADMITTED TO THE HOSPITAL FOR PERITONITIS. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. DURING A FOLLOW UP CALL ON (B)(6) 2011, THE FOLLOWING INFORMATION WAS PROVIDED: ON AN UNKNOWN DATE, THE PATIENT USED NIPPERS TO BREAK PD BAG FLANGE. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH CEFAMEZIN AND EXACIN. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RETRAINED. PER THE NURSE, THIS EVENT WAS NOT RELATED TO THE PD THERAPY AND THE CAUSE OF THE EVENT WAS THE PATIENT'S NONCOMPLIANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2.5| EXTRANEAL| HOMECHOICE