BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2112405 · Received June 3, 2011

    Report

    Report Number
    1423500-2011-07029
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 11A19H25 AND 10L14H25 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A CONSUMER FROM (B)(6) WITH FOLLOW UP INFORMATION FROM THE PD NURSE OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IT WAS UNKNOWN AS TO THE CAUSE OF THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS WAS NOT PROVIDED. FOLLOW-UP INFORMATION FROM THE PD NURSE WAS RECEIVED ON (B)(6) 2011. THIS CASE WAS MEDICALLY CONFIRMED. THE PD HCP (HEALTHCARE PROFESSIONAL) CONFIRMED THAT ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS. TREATMENT INCLUDED VANCOMYCIN (DRUG, DOSE AND START/STOP DATES NOT REPORTED). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECEIVED HIS LAST DOSE OF VANCOMYCIN. ON AN UNREPORTED DATE IN 2011 THE PATIENT RECOVERED FROM THE PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE COULD NOT IDENTIFY THE CAUSE OF THE PERITONITIS AND STATED SHE COULD NOT BE POSITIVE THAT IT WAS A BREAK IN ASEPTIC TECHNIQUE. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WITH (B)(6). WAS NOT RELATED TO DIANEAL THERAPY.

    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 62 YR Hospitalization| R DIANEAL PD4 AMBUFLEX