BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING TITANIUM ADAPTER FOR PERITONEAL DIAL CATH

    MDR report key: 1903723 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06028
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. THE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT IS UNKNOWN. SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. IF ADDITIONAL INFORMATION AND/OR THE SAMPLE BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A CUSTOMER REPORTED A CONNECTION ISSUE BETWEEN A TITANIUM ADAPTER AND A TRANSFER SET. THIS REPORT IS FOR THE TITANIUM ADAPTER. THE COMMUNITY CARE NURSE REPORTED THAT THIS EVENT OCCURRED ABOUT A MONTH AGO. THE HOME PATIENT (HP) WAS AT THE CLINIC ABOUT A MONTH AGO AS IT WAS HIS TIME TO GET HIS TRANSFER SET/ CATHETER CHANGED. THE NURSES AT THE HOSPITAL CHANGED THE CATHETER, THE TITANIUM ADAPTER AND THE TRANSFER SET ON THE HP. THE HP FINISHED HIS OVERNIGHT DIALYSIS TREATMENT. THE NURSE THEN VISITED THE HP ON A SATURDAY MORNING. AT SOME POINT IN THE MORNING THE HP'S WIFE STATED THAT THE HP'S PANTS WERE WET SO THE NURSE LOOKED AT THE CONNECTIONS AND NOTICED THAT THE TITANIUM ADAPTER HAD BROKEN OFF FROM THE PATIENT'S CATHETER. THE NURSE TOLD THE PATIENT TO IMMEDIATELY GO TO THE CLINIC AND THEY CHANGED THE ENTIRE SET UP AND THE HP WAS TREATED FOR A WET CONTAMINATION. THE HP WAS GIVEN INTRAPERITONEAL MEDICATION (ANCEF) AND THE EFFLUENT WAS SENT FOR LAB WORK. THE HP WAS THEN SENT HOME. THE HOME CARE NURSE THEN VISITED THE HP ON SUNDAY AND THE EFFLUENT WAS FINE. THE LAB RESULTS DID SHOW SOME SIGNS OF CONTAMINATION; THEREFORE, WHEN THE HP WENT BACK TO THE CLINIC THEY GAVE HIM VANCOMYCIN WHICH IS A 4 DAY DOSE. THE HP TOOK A DOSE ON A THURSDAY AND WAS SUPPOSED TO GO BACK ON A MONDAY (1 WEEK AFTER THE INCIDENT) FOR THE NEXT ROUND. HOWEVER, THE NURSE WENT TO SEE THE HP ON THE PREVIOUS SATURDAY AND THE NURSE STATED THAT THE HP HAD A FEVER, THE EFFLUENT WAS LIKE MILK AND HAD FIBRIN, AND THE HP HAD ABDOMINAL PAIN AND NAUSEA. THE HP WAS THEN TAKEN TO EMERGENCY DEPARTMENT. THE HP WAS IN THERE FOR 4 DAYS AND WAS GIVEN ANCEF AGAIN TO BE TAKEN UNTIL (B)(6) 2010. THE LAB RESULTS SHOWED THAT THE HP HAD PERITONITIS (SOME SORT OF STAPH INFECTION). SAMPLE AVAILABILITY IS UNKNOWN. UPON FOLLOW UP WITH THE HEALTHCARE PROFESSIONAL (HCP), THE HCP STATED THAT SHE DID NOT KNOW THE PRODUCT CODE OR THE LOT NUMBER OF THE TRANSFER SET. THE NURSE STATED THAT THE PATIENT WAS RECOVERING FROM THE INCIDENT. THE HCP MENTIONED THAT THE CONNECTION MAY HAVE BEEN LOOSE ON THE PATIENT AND AS HE WAS ROLLING ABOUT IN BED IT MAY HAVE COME OFF AND THE BED WAS WET. THE PATIENT DEVELOPED PERITONITIS BECAUSE THE TRANSFER SET WAS OFF THE PATIENT FOR A WHILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER FOR PERITONEAL DIAL CATH SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R