BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2180326 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09768
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 3, 2011
    Manufacturer
    BAXTER HEALTHCARE SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO BATCH REVIEW OR EVALUATION WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 ASSOCIATED WITH THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (10L14H25 & 11B10H25) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    INITIALLY, THE PATIENT CALLED AND STATED WHEN HE DID HIS I DRAIN THE SOLUTION COMING OUT WAS VERY CLOUDY. THE PATIENT CALLED THE FACILITY NURSE AND WAS INSTRUCTED TO END THERAPY AND DO MANUAL EXCHANGES THAT NIGHT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. DURING A FOLLOW UP CALL ON (B)(6) 2011, THE FACILITY NURSE PROVIDED THE FOLLOWING INFORMATION. THE PATIENT DID HAVE A CONFIRMED PERITONITIS IN (B)(6) 2011. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT WAS TREATED WITH FORTAZ 1GM EVERY DAY VIA INTRAPERITONEAL (IP) FOR FIVE DAYS AND VANCOMYCIN 1.5G IP EVERY WEEK TIMES THREE WEEKS. . THE PATIENT IS CONSIDERED RECOVERED FROM THIS EVENT. THE CAUSALITY WAS CONSIDERED DUE TO THE PATIENT NOT COVERING HIS MOUTH DURING THERAPY. THE PATIENT HAS BEEN RETRAINED AN ASEPTIC TECHNIQUE. NO FURTHER INFORMATION IS AVAILABLE RELATED TO THIS EVENT.

    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 61 YR Required Intervention HOMECHOICE| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)| DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4)