BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2023761 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03384
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (GD879908) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR - POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR(S) IDENTIFIED IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. 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 2 OF 3 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 NURSE IN THE USA OF A PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION, DID NOT WEAR A MASK, DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PERITONEAL DIALYSIS (PD), AND CONTRACTED PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PD. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE WHILE PERFORMING PD AND EXPERIENCED A TOUCH CONTAMINATION; THE PATIENT ALSO DID NOT WEAR A MASK, AND DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE PERITONITIS. THE TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. THE PD NURSE REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON AN UNREPORTED DATE IN 2011, THE PATIENT WAS RECOVERING. THE NURSE REPORTED THAT DIANEAL THERAPY WAS ONGOING.

    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 55 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX