BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2208766 · Received August 12, 2011

    Report

    Report Number
    1423500-2011-10638
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIALLY THIS EVENT WAS REPORTED ON A BAXTER MINICAP AND HAS BEEN CORRECTED TO METAL ADAPTER. ADDITIONAL INFORMATION WAS RECEIVED BY BAXTER PRODUCT SURVEILLANCE FROM THE PERITONEAL DIALYSIS NURSE (PDN). THE PDN CLARIFIED THAT THE ACTUAL POINT OF DISCONNECTION WAS BETWEEN THE PATIENT'S TRANSFER SET (MANUFACTURER REPORT 1423500-2011-10640) AND METAL ADAPTOR. REASON FOR DISCONNECTION WAS NOT PROVIDED. THE PDN BELIEVED THAT THE MANUFACTURER OF THE ADAPTOR IS MEDIGROUP, INC. (NON-BAXTER PRODUCT).

    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 1 OF 2 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 THE USA OF A PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION DESCRIBED AS THE TRANSFER SET FELL OFF AND THE PATIENT DID NOT CLEAN IT BEFORE PUTTING IT BACK ON. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS THAT RESULTED IN HOSPITALIZATION ON THE SAME DAY. TREATMENT WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2011, THE PATIENT RECOVERED FROM THE PERITONITIS. THE OUTCOME FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. DIANEAL UNKNOWN THERAPY WAS ONGOING. THE NURSE STATED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization DIANEAL UNKNOWN THERAPY| HOMECHOICE