BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2252091 · Received September 16, 2011

    Report

    Report Number
    1423500-2011-12346
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    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 FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD886036 AND GD885277 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS CONFIRMED. THE CAUSE OF THE USE ERROR WHICH RESULTED IN THE PERITONITIS WAS UNDETERMINED. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 2 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 FROM THE USA OF A PATIENT WHO DID NOT WEAR A MASK AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT DID NOT WEAR A MASK. TREATMENT AND OUTCOME WERE NOT REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THAT EVENT ON (B)(6) 2011. ON (B)(6) 2011, THE NURSE CONFIRMED THE DIAGNOSIS, START DATE, DATE OF ADMISSION, RECOVERY STATUS AND ONGOING PD THERAPY AS PREVIOUSLY REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE IN 2011, A PERITONEAL EFFLUENT CULTURE WAS OBTAINED. THE RESULTS SHOWED NO GROWTH. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFAZOLIN AND CEFTRIAXONE. THE NURSE COULD NOT CONFIRM THE CAUSE OF THE PERITONITIS AS PREVIOUSLY REPORTED BY THE CONSUMER. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY BUT DID NOT COMMENT ON THE EVENT OF DID NOT WEAR A MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX