BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2152116 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08735
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS USE ERROR- POOR ASEPTIC TECHNIQUE. THE BATCH REVIEW FOR POTENTIALLY ASSOCIATED LOT (GD883942) INDICATED NO DEFECTS OR DEVIATIONS ASSOCIATED WITH THIS PROBLEM. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. 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 EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF TWO REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER AND STATED THAT ON AN UNREPORTED DATE, SHE FOUND HER MINI-CAP OFF THE TRANSFER SET AND IN HER UNDERWEAR, MADE A MISTAKE AND TOUCH CONTAMINATED. BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) WHO STATED THAT ON (B)(6) 2011, THE HP WAS HOSPITALIZED FOR THE PERITONITIS. THE NURSE DID NOT KNOW THE CAUSE OF THE PERITONITIS, BUT STATED THAT IT WAS UNRELATED TO THE BAXTER PRODUCTS. THE HP WAS RECEIVING INTRAVENOUS (IV) AND ORAL ANTIBIOTICS. AT THE TIME OF THIS REPORT, THE HP HAD NOT YET RECOVERED FROM THE PERITONITIS AND A HOSPITAL DISCHARGE DATE WAS UNKNOWN.

    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 62 YR Hospitalization| R LOCAL (PD4) ULTRABAG| LOCAL (PD4) AMBUFLEX