BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1953385 · Received January 8, 2011

    Report

    Report Number
    1423500-2011-00322
    Event Type
    Injury
    Date Received
    January 8, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE FOURTH OF FOUR COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 10G15H25 AND 10E17H25 WITH NO ISSUES RELATING TO THE COMPLAINT OBSERVED DURING BATCH FILE REVIEWS. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE SECOND OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING AN UNRELATED ALARM. THE HP STATED SHE WAS ON ANTIBIOTICS FOR PERITONITIS. THE HP DID NOT KNOW HOW THE PERITONITIS DEVELOPED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE PDRN (B)(6) 2010. THEHP WAS HOSPITALIZED (B)(6) 2010. RECOVERY WAS ONGOING AND IMPROVED AT THE TIME OF THIS REPORT. CAUSALITY IS UNKNOWN. ALTHOUGH THE HP?S TECHNIQUE IS THOUGHT TO BE GOOD, THE HP WILL BE RETRAINED ON ASEPTIC TECHNIQUE UPON HER NEXT CLINIC APPOINTMENT.

    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 53 YR Hospitalization| R HOME CHOICE CYCLER| AMBUFLEX PD2