BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2142974 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08444
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 6, 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). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD882647 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. 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 2 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 PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) AND A PATIENT WHO MADE MISTAKE/TOUCH CONTAMINATION/DID NOT WEAR MASK/DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PERITONEAL DIALYSIS (PD) IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY FOR PD THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION/DID NOT WEAR MASK AND DID NOT EXCHANGE AREA BEFORE STARTING PD. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. TREATMENT INFORMATION WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO DIANEAL THERAPY. THE NURSE DID NOT COMMENT ON THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION/DID NOT WEAR MASK/DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD.

    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 35 YR Hospitalization DIANEAL PD2 AMBUFLEX| HOMECHOICE