BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2032196 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03767
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    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 2 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS GD879189 AND GD880757 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 NURSE FROM THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR E. COLI( ESCHERICHIA COLI) IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THAT ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. TREATMENTS FOR THE TOUCH CONTAMINATION AND PERITONITIS WERE NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN AND THE PATIENT'S PD CATHETER WAS PULLED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. THE NURSE STATED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR E. COLI WAS NOT RELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT REPORTED 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 44 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE PD CYCLER