BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1901984 · Received November 18, 2010

    Report

    Report Number
    1423500-2010-05910
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 27, 2010
    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. THIS IS REPORT 2 OF 3 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER; GD875567 WITH NO DEFECTS NOTED. THE ROOT CAUSE IS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(4) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER (B)(4), THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. IN (B)(6) 2010, THE PATIENT DEVELOPED AND WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNREPORTED. IT WAS UNREPORTED IF TREATMENT WAS PROVIDED. WHILE HOSPITALIZED, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. AT THE TIME OF THIS REPORT, IT WAS UNREPORTED IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS. PER THE NURSE, THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSEO.R. DEVICE WHICH ALARMED DURING DELIVERY, INTERRUPTING DELIVERY. THE REPORTED CONDITION OCCURRED IN THE ANESTHESIA UNIT, HOWEVER THE STEP IN THE PROCESS IN WHICH THE REPORTED CONDITION OCCURRED IS UNKNOWN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 37 YR Hospitalization THERAPY DIANEAL PD4 AMBUFLEX