BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2061880 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04669
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 29, 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). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H10H23052 AND H10I24066 WITH NO DEFECTS NOTED. 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 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) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR HEMOLYTIC STREPTOCOCCUS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE PATIENT REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, TOUCH CONTAMINATION OCCURRED AS REPORTED BY THE NURSE, ACCORDING TO THE PATIENT. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY PAIN WHICH HE EXPERIENCED "OVER THE WEEKEND" AND WENT BACK TO HIS DIALYSIS CLINIC FOR THAT REASON. THE PATIENT WAS SENT HOME WITH UNSPECIFIED MEDICATIONS THAT HE WAS TOLD TO PUT IN HIS BAGS UNTIL (B)(6) 2011 FOR THE PERITONITIS. THE OUTCOME FOR THE TOUCH CONTAMINATION WAS UNKNOWN. THE PERITONITIS RESOLVED ON AN UNKNOWN DATE IN 2011 AND PD THERAPY WAS ONGOING. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF TOUCH CONTAMINATION AND PERITONITIS.

    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 75 YR Required Intervention EXTRANEAL VIAFLEX| HOMECHOICE| DIANEAL PD4 AMBUFLEX