BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2173683 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09351
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 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). 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 FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD884445 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 CONSUMER REPORT FROM THE USA OF A PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION/DID NOT WEAR MASK/DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD/REUSED DISPOSABLES AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION/DID NOT WEAR MASK/DID NOT EXCHANGE AREA BEFORE STARTING PD AND REUSED DISPOSABLES, HOWEVER, THE CONSUMER WAS UNSURE AS TO WHICH CAUSED THE PERITONITIS. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. TREATMENT INFORMATION WAS NOT REPORTED. THE PATIENT WAS NOT HOSPITALIZED AND WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION/DID NOT WEAR MASK/DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD/REUSED DISPOSABLES WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. AN OPINION OF CAUSALITY 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 59 YR Other HOMECHOICE| DIANEAL PD4 AMBUFLEX