BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1911163 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06382
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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(S) 10G15H25 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE READ AS OVERHEATING ON THE CONSOLE WHILE BEING TESTED. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS NURSE REPORT FROM (B)(4) OF BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER (B)(4), THE REPORTING NURSE STATED THAT ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED THAT SAME DAY. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENTS. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. AT THE TIME OF THIS REPORT, THE PATIENT WAS IN THE HOSPITAL RECOVERING FROM THE PERITONITIS. PER THE NURSE, THE EVENT OF BACTERIAL PERITONITIS WITH (B)(6) WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP DISCONNECT CAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization DIANEAL PD4 AMBUFLEX