BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ADMIN. SET FOR USE WITH THE CARDIOGEN-82 INFUSION SYSTEM

    MDR report key: 3648008 · Received January 8, 2014

    Report

    Report Number
    2411512-2013-00017
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 11, 2013
    Report Date
    January 8, 2014
    Manufacturer
    BRACCO DIAGNOSTICS INC.
    Product Code
    JAK
    PMA / PMN Number
    883609
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ADMINISTRATION SET (PAS) FOR USE WITH CARDIOGEN-82 INFUSION SYSTEM IS A SINGLE USED, STERILE TUBING LINE FOR INTRAVENOUS ADMINISTRATION OF RUBIDIUM-82 TO THE PATIENT. IT HAS A LUER CONNECTION AT ONE END, TO CONNECT TO THE INFUSION SYSTEM CASSETTE LINE AND AN INLINE STERILE FILTER AND A LUER LOCK CONNECTOR TO CONNECT TO THE PATIENT CATHETER AT THE OTHER END. THE PAS IS USED TO ADMINISTER THE RUBIDIUM-82 ELUENT TO THE PATIENT AND TO PERFORM THE QUALITY CONTROL (QC) PROCEDURES. FOR THE PC PROCEDURES THE END WITH THE LUER LOCK AND THE FILTER IS PLACED IN A VIAL (QC ELUTION TEST VIAL) TO COLLECT THE RB-82 FROM A TEST RUN OF THE CARDIOGEN-82 INFUSION SYSTEM. THE ACCOUNT REPORTED A LOW PATIENT DOSE AND A PIN-HOLE LEAK IN THE FILTER OF THE PAS USED DURING THE QC PROCEDURES. A NEW PATIENT ADMINISTRATION SET IS USED FOR EACH PATIENT AND NO LEAKS WERE NOTED. BRACCO IS IN THE PROCESS OF HAVING THE PAS WHICH WAS REPORTED TO HAVE THE PIN-HOLE LEAK, RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION IS REQUIRED. COMPANY COMMENTS: THIS CASE, REPORTED BY A TECHNOLOGIST REFERS TO A LOW DOSE ACTIVITY OBTAINED DURING THE PERFORMANCE OF A MYOCARDIAL PERFUSION POSITION EMISSION TOMOGRAPHY (PET-MPI) STUDY WITH RUBIDIUM-82 IN A FEMALE PATIENT OF AN UNKNOWN AGE AND HISTORY. THE ROOT CAUSE FOR THE REPORTED LOW DOES OF RUBIDIUM-82 WAS THE PRESENCE OF A PINHOLE IN THE FILTER IN THE PATIENT ADMINISTRATION SET (PAS). DUE TO THE PRESENCE OF A LEAK IN THE FILTER, THE AMOUNT OF RADIOACTIVITY MEASURED WAS LOW AND THE DOSE CALIBRATION FACTOR AND ERRONEOUSLY CALCULATED. THIS CALIBRATION FACTOR WAS USED IN THE CALCULATION OF THE PATIENT DOES BY THE INFUSION SYSTEM. THEREFORE, THE PATIENT DOES WAS LOW BECAUSE THE CALIBRATION FACTOR WAS WRONG. ALSO, THE FILTER IS PLACED AT THE END OF THE PATIENT LINE TO ENSURE THE STERILITY OF THE ELUENT ADMINISTERED TO THE PATIENT. IF THE FILTER IS BROKEN OR DAMAGED, THE STERILITY OF THE ELUENT COULD BE COMPROMISED.

    Description of Event or Problem · 1

    NARRATIVE: ON (B)(6) 2013, A TECHNOLOGIST AT A USER FACILITY REPORTED THE FOLLOWING INFORMATION TO A (B)(4) ACCOUNT REPRESENTATIVE, WHO FORWARDED THE INFORMATION TO (B)(4) PROFESSIONAL SERVICES ON THE SAME DAY. ON (B)(4) 2013, THE INFORMATION WAS SENT TO (B)(4) DRUG SAFETY. ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER ON (B)(4) 2013 AND THE (B)(4) ACCOUNT REPRESENTATIVE ON (B)(4) 2013 WHICH WAS INTEGRATED INTO (B)(6)'S INITIAL REPORT. THE TECHNOLOGIST REPORTED. THEY EXPERIENCED LOW DOSE ACTIVITY FROM THE CARDIOGEN-82 INFUSION SYSTEM DURING THE CALIBRATION QUALITY CONTROL (QC) CHECK PERFORMED AT THE BEGINNING OF THE DAY ON (B)(6) 2013. THE DOSE CALIBRATOR MEASURED THE RADIOACTIVITY OF THE TEST ELUTION OF RUBIDIUM (RB-82) AS 20 MILLICURIES (MCI). THE PRINT-OUT OF THE TEST RUN FROM THE CARDIOGEN-82 INFUSION SYSTEM PRINTER SHOWED AN ACTIVITY OF ABOUT 50 MCI. BECAUSE THE TWO ASSAYS WERE NOT WITHIN 10%, A THIRD TEST RUN TO VERIFY THE NEW CALIBRATION FACTOR WAS PERFORMED AND THE ASSAYS FOR RADIOACTIVITY WERE WITHIN 10%. HOWEVER, THE NEW CALIBRATION FACTOR WAS VERY LOW. THE FIRST PATIENT SCANNED ON THE DAY WAS A FEMALE. A NEW PATIENT ADMINISTRATION SET (PAS) FOR USE WITH CARDIOGEN-82 INFUSION SYSTEM (PATIENT ADMINISTRATION SET) WAS USED FOR THE ADMINISTRATION OF THE RB-82 ELUENT FOR THE STUDY. THE STUDY WAS DIAGNOSTICALLY USEFUL, HOWEVER THE PRINT-OUT FROM THE INFUSION SYSTEM SHOWED THE PATIENT ONLY RECEIVED ABOUT 28 MCI OF RB-82 AND NOT THE INTENDED DOSE OF 50 MCI OF RB-82. ANOTHER DAILY QC CHECK WAS PERFORMED WHICH WAS WITHIN 10%. THEY DID NOT UNDERSTAND WHY THE PATIENT DOES OF RB-82 WAS LOW AND THE TECHNOLOGIST CALLED THEIR BRACCO ACCOUNT REPRESENTATIVE BEFORE SCANNING ANY MORE PATIENTS. AFTER UNDERGOING SEVERAL TROUBLESHOOTING PROCEDURES, IT WAS DISCOVERED THAT THE PAS, LOT# 61333252 WHICH WAS USED FOR THE DAILY QC CHECK PROCEDURE, HAD A PIN-HOLE LEAK ON THE SIDE OF THE 0.2 MICRON FILTER HOUSING. SOME OF THE RB-82 CONTAINING ELUATE LEAKED OUT OF THE PIN-HOLE AND THEREFORE NOT ALL OF THE ELUATE REACHED THE QC ELUTION TEST VIAL. THIS CAUSED THE LOW CALIBRATION FACTOR AND RESULTED IN A LOWER THAN INTENDED ADMINISTRATION OF RB-82 TO THE FIRST PATIENT OF THE DAY. THE TECHNOLOGIST VERIFIED THE LEAK BY MANUALLY PURGING SALINE THROUGH THE PATIENT ADMINISTRATION LINE WITH A SYRINGE AND VISUALLY OBSERVING A PIN-HOLE LEAK ON THE SIDE OF THE MICRON-FILTER. DURING AN ELUTION RUN, SOME OF THE ELUATE SPRAYED OUT OF THE PIN-HOLE LEAK OF THE FILTER AS FINE STREAM. THE REPORTER HAD NOTICED A SMALL WET SPOT ON THE TABLE AFTER THE FIRST QC CHECK BUT BELIEVED IT WAS FROM A CEILING LEAK AT THE TIME. THERE WAS ALSO A SMALL WET SPOT NOTICED AFTER THE SECOND QC CHECK BUT IN A DIFFERENT SPOT ON THE TABLE. NO STAFF MEMBER OR PATIENT WAS CONTAMINATED. THE TECHNOLOGIST REPEATED THE INFUSION SYSTEM CALIBRATION QC PROCEDURE WITH THE CALIBRATION FACTOR USED BEFORE IT WAS ADJUSTED. A NEW PAS WAS USED FOR THIS PROCEDURE. IT PASSED (WAS WITHIN 10%) AND RESULTED IN THE ELUTION RUN HAVING HIGHER PATIENT DOSE ACTIVITY ON THE PRINTOUT. THE BRACCO ACCOUNT REPRESENTATIVE REQUESTED THE TECHNOLOGIST HOLD ONTO THE PAS WITH THE PIN HOLE LEAK SO THAT IT COULD BE SENT IN TO BRACCO FOR EXAMINATION. IT WAS BELIEVED THE LEAK IN THE FILTER RESULTED IN A LOSS OF ABOUT 25 MCI OF THE 50 MCI ELUTION. THIS LED TO A CALIBRATION FACTOR WHICH WAS VERY LOW AND ACCOUNTED FOR THE INFUSION SYSTEM DELIVERING ABOUT 20 MCI TO THE FIRST PATIENT SCANNED. THE SYSTEM WORKED NORMALLY AND THEY CONTINUED TO SCAN PATIENTS FOR THE REST OF THE DAY AND DID NOT HAVE ANY ADDITIONAL PROBLEMS. ON (B)(4) 2013: THE (B)(4) ACCOUNT REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION. HE CLARIFIED THAT THE A NEW PAS WAS USED FOR THE PC CHECK WHICH WAS PERFORMED IN THE MORNING OF (B)(4) 2013. THE PAS WAS THEN USED FOR THE 2 ADDITIONAL QC CHECKS WHICH WERE PERFORMED ON THE SAME DAY. THE PAS WHICH WAS USED FOR THE PC CHECKS HAD THE PIN-HOLE LEAK. A NEW PAS WAS USED FOR THE PATIENT WHO HAD THE SCAN. ON (B)(4) 2013: ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTING TECHNOLOGIST. IT WAS CLARIFIED THAT, ON (B)(6) 2013, A NEW PAS WAS USED FOR THE DAILY QC CHECK. THE PAS WHERE THE PIN HOLE LEAK WAS OBSERVED WAS NEVER USED PREVIOUSLY FOR A QC CHECK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12678 PATIENT ADMIN. SET FOR USE WITH THE CARDIOGEN-82 INFUSION SYSTEM PATIENT ADMINISTRATION SET JAK BRACCO DIAGNOSTICS INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other