BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2182901 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09895
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 6, 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).A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER 10L14H25 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. 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 REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 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 (B)(6) OF HOLE IN THE PERITONEUM, CONSTIPATION AND PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE ORGANISM IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN AND DIANEAL PD4 AMBUFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT EXPERIENCED CONSTIPATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS THAT DID NOT RESULT IN HOSPITALIZATION. THE CONSUMER STATED THAT THE BACTERIAL PERITONITIS WAS CAUSED BY CONSTIPATION WHICH CAUSED A HOLE IN THE PERITONEUM. THE NURSE DID NOT KNOW THE CAUSE OF THE PERITONITIS. TREATMENT FOR THE EVENTS WAS NOT REPORTED. THE OUTCOME FOR THE CONSTIPATION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. DIANEAL UNKNOWN AND DIANEAL PD4 AMBUFLEX THERAPIES WERE ONGOING. THE NURSE STATED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE ORGANISM WAS UNRELATED TO DIANEAL THERAPIES. THE NURSE DID NOT COMMENT ON OR CONFIRM THE CONSTIPATION OR HOLE IN THE PERITONEUM AS REPORTED BY THE CONSUMER AND AN OPINION OF CAUSALITY WAS NOT PROVIDED.

    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 42 YR Other DIANEAL| HOMECHOICE| DIANEAL PD4 AMBUFLEX