BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2032895 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03802
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW FOR THE POTENTIALLY ASSOCIATED LOT NUMBER (10J15H25) REVEALED NO DEVIATIONS DURING THE MANUFACTURE OF THIS BATCH. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 4 OF 5 FOR THIS INCIDENCE OF PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER ON (B)(6) 2011 FOR AN UNRELATED ALARM AND VERBALIZED THAT SHE HAD PERITONITIS. DURING A FOLLOW CALL ON (B)(6) 2011 WITH THE PERITONEAL DIALYSIS (PD) RN, SHE CONFIRMED THAT THE PATIENT HAD PERITONITIS IN (B)(6) 2011. THE PATIENT WAS TREATED WITH AN UNKNOWN DOSE OF TOBRAMYCIN AND VANCOMYCIN PRIOR TO RECEIVING THE PD CULTURE RESULTS. AFTER THE PD CULTURE WAS RECEIVED (ON AN UNKNOWN DATE) THE PATIENT WAS TREATED WITH VACOMYCIN AND FORTAZ 1GM INTRAPERITONEALLY FOR 10 DAYS. THE PD RN REPORTED THAT THE PATIENT MAY HAVE FORGOTTEN THE LAST HAND SANITIZING BEFORE STARTING THERAPY. SHE HAS REVIEWED PROPER ASEPTIC TECHNIQUE WITH THE PATIENT. THE PATIENT HAS RECOVERED AND CONTINUES PD THERAPY WITHOUT INCIDENT. THERE WAS NO FURTHER INFORMATION AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DIANEAL LOCAL (PD4) AMBUFLEX| HOME CHOICE CYCLER