BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2192047 · Received August 4, 2011

    Report

    Report Number
    1423500-2011-10282
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS: H10I30048, H10K05047, H11A03058, H11B07024, H11D12038, H11C31030, AND H11E09049 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.

    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 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(4) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF A PATIENT THAT MADE A MISTAKE WITH TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE A MISTAKE WITH TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AS A RESULT OF THE TOUCH CONTAMINATION. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011 TO (B)(6) 2011 AND THE PERITONITIS RESOLVED ON AN UNREPORTED DATE IN 2011. TREATMENT WAS NOT REPORTED. OUTCOME FOR THE PATIENT'S MISTAKE WITH TOUCH CONTAMINATION WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE REPORTER STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE REPORT OF TOUCH CONTAMINATION.

    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 72 YR Hospitalization DIANEAL PD4 AMBUFLEX