BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1882219 · Received October 26, 2010

    Report

    Report Number
    1423500-2010-04930
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER(S) GD877274, GD876482 AND GD875567 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR 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 4 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTING A FALSE POSITIVE RESULT IN THE ANTI-D MICRO WELL TO A PATIENT WHO HAD A PREVIOUS HISTORY OF BEING RH NEGATIVE. THE D MICROTUBE REACTED 3+. CUSTOMER STATED THAT WITH TUBE METHOD, INCLUDING WEAK D TESTING, SAMPLE IS REACTING AS RH NEGATIVE. CUSTOMER CLAIMED UPON FURTHER INSPECTION, THE GEL CARDS IN QUESTIONS HAD SIGNS OF LOW LIQUID LEVELS. NO ERRONEOUS RESULTS WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE OF A BREAK IN ASEPTIC TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE CAREGIVER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SERVICE ALARM ON THE HOMECHOICE. DURING THE CALL, THE CAREGIVER REPORTED THAT THE PATIENT WAS IN THE HOSPITAL. IN (B)(6) 2010, THE PD NURSE PROVIDED FURTHER INFORMATION. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. THE NURSE STATED THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010 AND ADMITTED TO THE HOSPITAL THAT SAME DAY. ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS TREATED WITH VANCOMYCIN 2.5 GRAMS IP EVERY FIVE DAYS (4 DOSES). ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT OF PERITONITIS WAS RESOLVING. DIANEAL THERAPY WAS ONGOING. THE NURSE BELIEVED THE ALTERNATIVE ETIOLOGY FOR THE PERITONITIS WAS TOUCH CONTAMINATION. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE. THE NURSE STATED THE CAUSALITY FOR THE EVENT OF PERITONITIS WAS UNASSESSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG