BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2082503 · Received May 10, 2011

    Report

    Report Number
    1423500-2011-05686
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD882241, GD881474 AND GD880799 AND NO EXCEPTIONS WERE OBSERVED THAT WERE 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.

    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 A PATIENT WHO MADE MISTAKE / TOUCH CONTAMINATION / DID NOT WEAR A MASK / DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PERITONEAL DIALYSIS (PD), EXIT SITE INFECTION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE / TOUCH CONTAMINATION / DID NOT WEAR A MASK / DID NOT CLEAN THE EXCHANGE AREA BEFORE STATING PD. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS NOT HOSPITALIZED. THE CAUSE OF PERITONITIS WAS ATTRIBUTED TO THE PATIENT MADE MISTAKE / TOUCH CONTAMINATION / DID NOT WEAR A MASK / DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD. TREATMENTS WERE NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. THE OUTCOME FOR THE EVENTS OF PATIENT MADE MISTAKE / TOUCH CONTAMINATION / DID NOT WEAR A MASK / DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD AND EXIT SITE INFECTION WAS UNKNOWN. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THE PERITONITIS WERE UNRELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY FOR THE EVENTS OF THE PATIENT MADE MISTAKE / TOUCH CONTAMINATION / DID NOT WEAR A MASK / DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD AND EXIT SITE INFECTION WAS NOT REPORTED.

    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 58 YR Other DIANEAL PD4 ULTRABAG