BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1830010 · Received September 10, 2010

    Report

    Report Number
    1423500-2010-03328
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 20, 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). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS FOR THE MINICAP (GD875567 AND GD873919) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. 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 IS A SPONTANEOUS REPORT BY A NURSE REGARDING BACTERIAL PERITONITIS IN A (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. DURING A CALL WITH BAXTER (B)(4), THE REPORTING NURSE STATED THAT ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS (B)(6). TREATMENT INFORMATION WAS NOT PROVIDED. IT WAS NOT REPORTED WHETHER PERITONEAL DIALYSIS THERAPY WAS ONGOING AT THE TIME OF THE EVENT. THE PATIENT WAS RECOVERING FROM THE EVENT. PER THE NURSE, THE BACTERIAL PERITONITIS WAS NOT RELATED TO PD THERAPY.

    Description of Event or Problem · 1

    BECKMAN COULTER INC. (BCI) CONTACTED THIS CUSTOMER VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI PATIENT RESULTS. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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 44 YR Hospitalization| R DIANEAL PD4 AMBU-FLEX