BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2023757 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03379
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 23, 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

    COMPLAINT NO: (B)(4) BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT (GD877282) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THAT LOT. 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.

    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 CONSUMER IN THE USA, WITH SUPPLEMENTAL INFORMATION BY A NURSE, OF A PATIENT WHO MADE A MISTAKE / TOUCH CONTAMINATION AND EXPERIENCED PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S WIFE REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. UPON A FOLLOW-UP CALL WITH THE PATIENT'S NURSE, THE NURSE STATED THAT ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE WHILE PERFORMING THERAPEUTIC PD AND EXPERIENCED A TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. IN (B)(6) 2010, PERITONEAL EFFLUENT CULTURE WAS OBTAINED WHICH REVEALED NO GROWTH. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT HAD RECOVERED. THE OUTCOME FOR THE TOUCH CONTAMINATION WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS DISCONTINUED. PER THE NURSE, THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY, RATHER WAS RELATED TO THE TOUCH CONTAMINATION. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE TOUCH CONTAMINATION.

    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 71 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE