BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2220786 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11110
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER: H10L07041 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    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 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF A BREAK IN ASEPTIC TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THAT EVENT ON (B)(6) 2011. TREATMENT WAS NOT REPORTED AND ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT HAD RECOVERED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. DIANEAL THERAPIES WERE ONGOING. FOLLOW UP INFORMATION WAS OBTAINED FROM THE NURSE: THE NURSE STATED THE EVENT WAS NOT RELATED TO DIANEAL THERAPIES. THE NURSE STATED THAT IN 2011, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE THAT RESULTED IN PERITONITIS IN 2011. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 FOR THE PERITONITIS. ON AN UNREPORTED DATE IN 2011, THE PATIENT RECEIVED VANCOMYCIN (IP, DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IN (B)(6) 2011, THE PATIENT RECOVERED FROM THE BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE BREAK IN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG