BEUDAMED
    FDA Adverse Event Other Summary report: N

    PATIENT ADMIN. SET FOR USE WITH THE

    MDR report key: 4073086 · Received August 25, 2014

    Report

    Report Number
    2411512-2014-00003
    Event Type
    Other
    Date Received
    August 25, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    BRACCO DIAGNOSTICS INC.
    Product Code
    FPK
    PMA / PMN Number
    K883609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ADMINISTRATION SET (PAS) FOR USE WITH CARDIOGEN-82 INFUSION SYSTEM IS A SINGLE USE DEVICE, STERILE TUBING LINE. IT IS USED FOR INTRAVENOUS ADMINISTRATION OF THE NUCLEAR MEDICINE IMAGING AGENT RUBIDIUM-82 (RB-82) TO THE PATIENT. IT IS 42 INCHES LONG AND HAS A LUER CONNECTION AT ONE END USED TO CONNECT TO THE CARDIOGEN-82 INFUSION SYSTEM INFUSION (ALSO A BRACCO PRODUCT) SYSTEM CASSETTE LINE, AN INLINE STERILE FILTER A ONE WAY CHECK VALVE AND A LUER LOCK CONNECTOR AT THE OTHER END TO CONNECT TO THE PATIENT CATHETER. THE PATIENT ADMINISTRATION SET THAT WAS USED ON THE FEMALE PATIENT AND THE (B)(6) YEAR-OLD MALE PATIENT WAS NOT RETURNED TO BRACCO. THE IMAGING FACILITY STAFF IS IN THE PROCESS OF ARRANGING FOR TESTING OF THE FEMALE PATIENT. THE PATIENT ADMINISTRATION SET LABEL STATES THAT "THIS PRODUCT IS FOR SINGLE USE ONLY". THE LABEL ALSO DISPLAYS THE INTERNATIONAL SYMBOL FOR SINGLE USE ONLY (A CIRCLE WITH A '2' AND A SLASH THROUGH THE '2'). THE TABLE WHICH EXPLAINS THE SYMBOL AS SINGLE USE ONLY IS ALSO INCLUDED ON THE LABEL. COMPANY COMMENTS: THIS CASE REPORTED BY A TECHNOLOGIST REFERS TO A RE-USE OF THE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) THAT IS INTENDED FOR SINGLE USE ONLY IN A(B)(6) YEAR-OLD MALE PATIENT UNDERGOING CARDIAC PET (POSITRON EMISSION TOMOGRAPHY) IMAGING. THE SINGLE USE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) CONNECTS THE GENERATOR TUBING SET TO THE DELIVERY SITE WHICH TYPICALLY CONSISTS OF ANOTHER TUBING SET (NOT PROVIDED WITH THE CARDIOGEN-82 SYSTEM)¿WHICH PROVIDES ACCESS TO THE PATIENT'S VASCULAR SYSTEM. THE SINGLE USE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) CONTAINS ITS OWN STERILIZING FILTER. THE ENTIRE PATIENT ADMINISTRATION SET MUST BE CHANGED AS A NEW PATIENT IS BEING IMAGED. IN THE REPORTED OCCURRENCE, THE SINGLE USE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) THAT WAS ALREADY USED ON A PREVIOUS PATIENT WAS NOT REPLACED EVEN THOUGH IT WAS ATTACHED TO A NEW PATIENT ADMINISTRATION SET (BRACCO PRODUCT). ALTHOUGH NO HARM WAS REPORTED FOR THE PATIENT AS IT OCCURRED, BRACCO FEELS THE REPORT SHOULD BE PROCESSED AS A REPORTABLE MDR TO THE FDA DUE TO POSSIBLE COMPROMISE OF STERILITY. HOWEVER, IT IS NOTEWORTHY THAT THE CARDIOGEN-82 USER GUIDE CLEARLY STATES THAT THE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) IS SINGLE USE ONLY AND THAT RE-USE CARRIES RISK OF CROSS CONTAMINATION. ADDITIONALLY, THE PATIENT ADMINISTRATION SET LABEL (BRACCO PRODUCT) ALSO CLEARLY STATES THAT THE PRODUCT IS FOR SINGLE USE ONLY. THE IMAGING FACILITY STAFF HAS CONTACTED THE FEMALE PATIENT'S PHYSICIAN TO ARRANGE FOR PERMISSION FOR A BLOOD DRAW TO PERFORM TESTING IN ACCORDANCE WITH THE FACILITY'S POLICIES. ADDITIONAL INFORMATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    JUNE 8, 2015: BRACCO'S QUALITY GROUP REVIEWED THE CASE AND SENT THEIR FINDINGS TO BRACCO'S DRUG SAFETY GROUP. THE QUALITY GROUP FINDINGS WERE; THIS CASE REFERS TO A RE-USE OF THE PATIENT ADMINISTRATION SET THAT IS INTENDED FOR SINGLE USE ONLY. THE CARDIOGEN-82 USER GUIDE CLEARLY STATES THAT THIS ADMINISTRATION SET IS SINGLE USE ONLY AND THAT RE-USE CARRIES RISK OF CROSS CONTAMINATION. THE RISK ASSESSMENT HAS BEEN REVIEWED IN RELATION TO THIS ISSUE, AND NO CHANGE WAS DEEMED NECESSARY. IN ADDITION, THE BRACCO CLINICAL APPLICATIONS SPECIALIST HAS FOLLOWED UP WITH THE FACILITY TO ASSURE THE CUSTOMER IS AWARE THIS IS A SINGLE USE ITEM. THEY WERE REMINDED TO KNOW THE DIFFERENCE BETWEEN THE END OF THE INFUSION SYSTEM LINE AND THE END OF A PATIENT ADMINISTRATION LINE SO THAT TWO PATIENT LINES WOULD NOT BE ATTACHED TOGETHER IN THE FUTURE. NO FURTHER INVESTIGATION RELATED TO THIS ISSUE IS WARRANTED AT THIS TIME. THIS CASE IS MEDICALLY CLOSED. COMPANY COMMENTS: THIS CASE REPORTED BY A TECHNOLOGIST REFERS TO A RE-USE OF THE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) THAT IS INTENDED FOR SINGLE USE ONLY IN A (B)(6) MALE PATIENT UNDERGOING CARDIAC PET (POSITRON EMISSION TOMOGRAPHY) IMAGING. THE SINGLE USE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) CONNECTS THE GENERATOR TUBING SET TO THE DELIVERY SITE WHICH TYPICALLY CONSISTS OF ANOTHER TUBING SET (NOT PROVIDED WITH THE CARDIOGEN-82 SYSTEM) WHICH PROVIDES ACCESS TO THE PATIENT'S VASCULAR SYSTEM. THE SINGLE USE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) CONTAINS ITS OWN STERILIZING FILTER. THE ENTIRE PATIENT ADMINISTRATION SET MUST BE CHANGED AS A NEW PATIENT IS BEING IMAGED. IN THE REPORTED OCCURRENCE, THE SINGLE USE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) THAT WAS ALREADY USED ON A PREVIOUS PATIENT WAS NOT REPLACED EVEN THOUGH IT WAS ATTACHED TO A NEW PATIENT ADMINISTRATION SET (BRACCO PRODUCT). ALTHOUGH NO HARM WAS REPORTED FOR THE PATIENT AS IT OCCURRED, BRACCO FEELS THE REPORT SHOULD BE PROCESSED AS A REPORTABLE MDR TO THE FDA DUE TO POSSIBLE COMPROMISE OF STERILITY. HOWEVER, IT IS NOTEWORTHY THAT THE CARDIOGEN-82 USER GUIDE CLEARLY STATES THAT THE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) IS SINGLE USE ONLY AND THAT RE-USE CARRIES RISK OF CROSS CONTAMINATION. ADDITIONALLY, THE PATIENT ADMINISTRATION SET LABEL (BRACCO PRODUCT) ALSO CLEARLY STATES THAT THE PRODUCT IS FOR SINGLE USE ONLY. THE IMAGING FACILITY STAFF HAS CONTACTED THE FEMALE PATIENT'S PHYSICIAN TO ARRANGE FOR PERMISSION FOR A BLOOD DRAW TO PERFORM TESTING IN ACCORDANCE WITH THE FACILITY'S POLICIES. QUALITY INVESTIGATION WAS CONDUCTED AND NO CHANGE WAS DEEMED NECESSARY. IN ADDITION, THE BRACCO CLINICAL APPLICATION SPECIALIST HAS FOLLOWED UP WITH THE FACILITY TO ASSURE THE CUSTOMER IS AWARE THIS IS A SINGLE USE ITEM.

    Description of Event or Problem · 1

    NARRATIVE: ON (B)(6) 2014, TECHNOLOGIST AT A PET (POSITRON EMISSION TOMOGRAPHY) IMAGING CENTER REPORTED. ON (B)(6) 2014, A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A CARDIAC RB-82 REST PHASE STRESS TEST. THE PATIENT'S MEDICAL HISTORY INCLUDED CARDIAC SARCOIDOSIS. PREVIOUSLY ABOUT A WEEK EARLIER, HE UNDERWENT TWO IMAGING STUDIES AT THE FACILITY. A CARDIAC SARCOID STUDY WAS PERFORMED USING THE PET NUCLEAR MEDICINE AGENT FLUORO-DEOXYGLUCOSE (FDG) WHICH IS F18 RADIOLABELED GLUCOSE. THE FDG IS INJECTED INTRAVENOUSLY AND HAS REDUCED LOCALIZATION IN ISCHEMIC TISSUE AND IS THEREFORE USEFUL FOR PET CARDIAC VIABILITY IMAGING STUDIES. THE OTHER STUDY PERFORMED ON THE PATIENT THAT DAY WAS A CARDIAC STRESS RB-82 STUDY. LEXISCAN (REGADENOSON) WAS INTRAVENOUSLY ADMINISTERED AS THE STRESS AGENT. BOTH STUDIES WERE WITHOUT INCIDENT. THE PATIENT'S CONCOMITANT MEDICATIONS AND ADDITIONAL MEDICAL HISTORY WERE NOT KNOWN TO THE REPORTER. PRIOR TO UNDERGOING THE CURRENT RB-82 STUDY ON (B)(6) 2014, A FEMALE PATIENT WAS IMAGED WITH RB-82 AND THEN MOVED OUT OF THE PET SUITE TO BE PREPARED FOR AN FDG STUDY. THE PATIENT ADMINISTRATION SET (BRACCO PRODUCT) USED FOR HER INFUSION WAS NOT DISCONNECTED FROM THE CARDIOGEN-82 INFUSION SYSTEM TUBING USED FOR HER IMAGING STUDY. FOR IMAGING OF THE (B)(6) YEAR-OLD MALE PATIENT, A NEW PATIENT ADMINISTRATION SET (BRACCO PRODUCT) WAS ATTACHED VIA THE LEUR LOCK CONNECTORS TO THE USED PATIENT ADMINISTRATION SET (BRACCO PRODUCT) THAT WAS FROM THE PREVIOUS FEMALE PATIENT (THE TWO ADMINISTRATIONS SET WERE CONNECTED IN TANDEM). THE LOT NUMBER FOR BOTH OF THE ADMINISTRATIONS SETS WAS 61360636. THE IMAGE STUDY WAS PERFORMED AND THE QUALITY FROM THE MALE PATIENT'S REST PHASE (RB-82 CARDIAC STRESS TEST) WAS EXCELLENT. THE PRINTOUT FROM THE CARIDOGEN-82 INFUSION SYSTEM WHICH DOCUMENTS THE ADMINISTRATION WAS NORMAL. THE PRINTOUT SHOWED THE PATIENT WAS ADMINISTERED 40.1 MILLICURIES (MCI) OF RB-82 IN A VOLUME OF 16 ML. THE IMAGING FACILITY STAFF HAS CONTACTED THE FEMALE PATIENT'S DOCTOR IN ACCORDANCE WITH THE IMAGING FACILITIES POLICIES TO ARRANGE FOR PERMISSION TO ARRANGE FOR A BLOOD DRAW AND TO PERFORM TESTING. THE MALE PATIENT'S PHYSICIAN WAS ALSO NOTIFIED OF THE OCCURRENCE. HOWEVER, IF THE FEMALE PATIENT DOES NOT GRANT PERMISSION, THE MALE PATIENT MAY BE ASKED FOR PERMISSION TO TEST HIM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510958 PATIENT ADMIN. SET FOR USE WITH THE PATIENT ADMINISTRATION SET FPK BRACCO DIAGNOSTICS INC. NI 61360636

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other