BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1801818 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02528
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (GD873927) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED FOR A PERITONITIS EVENT. THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA RECEIVED ON (B)(6) 2010 OF CRAMPS AND CLOUDY EFFLUENT IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT EXPERIENCED CRAMPS AND CLOUDY EFFLUENT. ON (B)(6) 2010, A SAMPLE OF THE CLOUDY EFFLUENT WAS SENT FOR ANALYSIS BUT RESULTS WERE PENDING AT THE TIME OF REPORTING. THE PATIENT WAS NOT HOSPITALIZED FOR THE CRAMPS AND CLOUDY EFFLUENT. TREATMENT FOR THE CRAMPS AND CLOUDY EFFLUENT WERE NOT REPORTED. IT WAS NOT REPORTED WHETHER DIANEAL PD4 AMBUFLEX THERAPY WAS ONGOING. THE PATIENT HAD NOT RECOVERED FROM THE CRAMPS AND CLOUDY EFFLUENT AT THE TIME OF REPORTING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE CRAMPS AND CLOUDY EFFLUENT WERE UNRELATED TO DIANEAL PD4 AMBUFLEX THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE TROCAR WAS LEAKING IMMEDIATELY BEFORE ANY INSTRUMENTS WERE INSERTED AND WAS REPLACED WITH A SLEEVE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention DIANEAL PD4 AMBUFLEX