BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2256772 · Received September 21, 2011

    Report

    Report Number
    1423500-2011-12456
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR-BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED. THE ASSIGNABLE CAUSE IS NOT DETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER GD884452. NO DEFECTS OR DEVIATIONS WERE FOUND DURING THE BATCH REVIEW THAT COULD BE ASSOCIATED WITH THE REPORTED PROBLEM. A LABELING REVIEW WAS PERFORMED WHICH FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    INITIALLY THE PERITONEAL DIALYSIS (PD) HOME PATIENT'S (HP) CAREGIVER (CG) CONTACTED BAXTER TECHNICAL SERVICE AND REPORTED THAT THE HP IS TRAVELING AND HAD TO GO INTO THE HOSPITAL BECAUSE OF PERITONITIS. ON (B)(6) 2011 BAXTER PRODUCT SURVEILLANCE (PS) FOLLOWED UP ON THE REPORT OF PERITONITIS WITH THE PATIENT'S PERITONEAL DIALYSIS NURSE (PDN). THE FOLLOWING INFORMATION WAS OBTAINED. THE PDN CONFIRMED THE HP WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2011 AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN 2.5 GM Q 5. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PDN REPORTED THAT THE HP HAS RECOVERED FROM THE EVENT OF PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PDN REPORTED THAT THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE DUE TO THE HP NOT WEARING A MASK AND NOT CLEANING THE AREA BEFORE STARTING PD THERAPY. THE PDN STATED THAT RETRAINING IN PROPER ASEPTIC TECHNIQUE WAS DONE. THE PDN CONFIRMED THAT THE CAUSE OF THE PERITONITIS WAS NOT RELATED TO A BAXTER PD SOLUTION OR A BAXTER PD DEVICE.

    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 63 YR Hospitalization| R EXTRANEAL ICODEXTRIN| DIANEAL LOW CA (B)(4)