BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2022706 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03341
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    November 1, 2010
    Report Date
    February 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER GD877274 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) THROUGH A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF INFECTIONS AND PERITONITIS WITH CULTURE POSITIVE FOR OCHROBACTRUM ANTHROP IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX, DIANEAL PD2 ULTRABAG, AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE PATIENT REPORTED THAT HE HAD DIFFICULTIES WITH PD INCLUDING INFECTIONS AND PERITONITIS. UPON A FOLLOW UP WITH THE NURSE, IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT EXPERIENCED PERITONITIS. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE NURSE REPORTED THAT HIS PD ASEPTIC TECHNIQUE WAS EXCELLENT SO SHE DID NOT KNOW HOW HE DEVELOPED THE PERITONITIS. TREATMENT (NOT SPECIFIED) WAS INEFFECTIVE IN ERADICATING THE PERITONITIS. ON (B)(6) 2011, SINCE THE PERITONITIS WAS NOT RESOLVED, DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN AND PERMANENT HEMODIALYSIS WAS STARTED. THE NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO THE DIANEAL AND EXTRANEAL THERAPIES. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. SHE DID NOT COMMENT ON THE INFECTIONS REPORTED BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other HOMECHOICE CYCLER| EXTRANEAL VIAFLEX| DIANEAL PD2 ULTRABAG| DIANEAL PD2 AMBUFLEX