BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1832211 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03358
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN, AND PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBER (GD873919), WITH NO DEFECTS NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IT WAS UNKNOWN WHETHER A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENTS. PD THERAPY WAS ONGOING AT THE TIME OF THE EVENT. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION RESOLVED OR WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE PATIENT'S MEDICAL HISTORY WAS UNKNOWN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE PERITONITIS WAS NOT RELATED TO PD THERAPY. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN MR850 RESPIRATORY HUMIDIFIER WAS DISPLAYING ERRATIC TEMPERATURE READINGS, AND AT ONE POINT, IT REACHED 47.4°C WITH A GAS FLOW OF 6LPM. A BC2425 NEONATAL OXYGEN THERAPY NASAL CANNULA APPEARED TO BE FLEXING BACK IN THE PATIENT'S NOSE, CAUSING BLOCKAGE TO THE GAS FLOW. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 AMBUFLEX