BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2091699 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06074
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 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). THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER (10L14H25). THERE WERE NO ISSUES DETECTED DURING PRODUCTION OF THIS BATCH. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE IN (B)(6) OF PANCREATITIS AND CHEST PAIN COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) AND DIANEAL PD4 ULTRABAG INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2011, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WITH CULTURE RESULTS UNKNOWN. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED CHEST PAIN. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS AND CHEST PAIN. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE ON (B)(6) 2011: THE NURSE STATED ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PANCREATITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THAT EVENT. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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 56 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE| DIANEAL PD4 ULTRABAG