BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOGEN 82 INFUSION SYSTEM

    MDR report key: 11558158 · Received March 23, 2021

    Report

    Report Number
    2411512-2021-00002
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 22, 2021
    Product Code
    OIP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED FROM A HEALTHCARE PROFESSIONAL BY (B)(4) ON 18-FEB-2021 AS A NON-VALID REPORT DUE TO LACK OF PATIENT IDENTIFIERS. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS PROVIDED INCLUDING PATIENT IDENTIFIERS AND THE CASE BECAME VALID, ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THIS CASE DESCRIBES THE OCCURRENCE OF EXTRAVASATION AND DRUG INEFFECTIVE IN A FEMALE INPATIENT WHO UNDERWENT AN UNKNOWN DIAGNOSTIC PROCEDURE ON (B)(6) 2021 DUE TO AN UNKNOWN REASON. MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND ALLERGIES WERE UNKNOWN. IT WAS NOT KNOWN IF THE PATIENT RECEIVED CONTRAST IN THE PAST. ON (B)(6) 2021, FOLLOWING INTRAVENOUS (IV) ADMINISTRATION OF AN UNKNOWN DOSE OF CARDIOGEN (RUBIDIUM 82) (LOT # 09101210291) (LINKED DRUG CASE, (B)(4)) VIA CARDIOGEN 82 INFUSION SYSTEM PATIENT ADMINISTRATION SET (LOT # AND UDI # NA), THERE WAS A PARTIAL IMAGE OBTAINED WHICH WAS GRAINY AND NOT DIAGNOSTICALLY USEFUL (DRUG INEFFECTIVE). ACCORDING TO THE RADIOLOGIST, THERE MUST HAVE BEEN A POSSIBLE EXTRAVASATION IN THE INTRAVENOUS (IV) ANTECUBITAL SITE. HOWEVER, UPON EXAM OF THE PATIENT'S INTRAVENOUS (IV) SITE WHERE THE CARDIOGEN WAS GIVEN (REPORTER DID NOT RECALL WHICH ARM), THERE WAS NO REDNESS, NO SWELLING OR ANY OTHER SIGN OF INFILTRATION/EXTRAVASATION AT THE SITE OF INFUSION. THE PATIENT DID NOT COMPLETE THE EXAM AND WAS SENT BACK TO THE FLOOR. ON (B)(6) 2021, THE PATIENT WAS BROUGHT BACK FOR THE STRESS PORTION OF THE EXAM, THE REPORTER STATED THE SAME CARDIOGEN (RUBIDIUM 82) (LOT #: 09101210291) WAS USED. AN UNKNOWN DOSE OF CARDIOGEN WAS ADMINISTERED IN A DIFFERENT INTRAVENOUS (IV) SITE LOCATION, ALL IMAGES WERE OBTAINED WITHOUT INCIDENT AND WERE DIAGNOSTICALLY USEFUL. THE PATIENT WAS ALSO EXAMINED AGAIN BY THE RADIOLOGIST AND THERE WERE NO SIGNS OF EXTRAVASATION AT THE INJECTION SITE FROM THE PREVIOUS EXAM ON (B)(6) 2021. NO TREATMENTS WERE PRESCRIBED OR GIVEN. THE ACCOUNT REPORTED THERE WAS A PARTIAL IMAGE OBTAINED, WHICH WAS GRAINY AND NOT DIAGNOSTICALLY USEFUL. THE ACCOUNT CONSIDERED THERE MUST HAVE BEEN AN EXTRAVASATION IN THE IV ANTECUBITAL SITE. NO INVESTIGATION IS REQUIRED BY THE CMO SINCE THERE WAS NO DEVICE FAILURE REPORTED NOR IS THERE REASON TO SUGGEST THERE WAS ANY MALFUNCTION WITH EITHER THE INFUSION SYSTEM OR RELATED ACCESSORY PRODUCTS. THE COMPLAINT HAS BEEN RECORDED SOLELY FOR TRACKING AND TRENDING PURPOSES. NO FURTHER INFORMATION WAS AVAILABLE FOR THIS REPORT. THIS CASE IS MEDICALLY CLOSED WITH THE INFORMATION AT HAND. WORLD WIDE ID #: (B)(4). BRACCO COMMENT: A FEMALE INPATIENT UNDERWENT AN UNKNOWN DIAGNOSTIC PROCEDURE WITH CARDIOGEN 82 INFUSION SYSTEM DUE TO AN UNKNOWN REASON. FOLLOWING INTRAVENOUS ADMINISTRATION OF AN UNKNOWN DOSE OF CARDIOGEN (RUBIDIUM 82) VIA THE CARDIOGEN 82 INFUSION SYSTEM PATIENT ADMINISTRATION SET, REPORTEDLY, ONLY A PARTIAL IMAGE WAS OBTAINED WHICH WAS GRAINY AND NOT DIAGNOSTICALLY USEFUL (DRUG INEFFECTIVE). SUSPECTING EXTRAVASATION, THE INJECTION SITE WAS EXAMINED BUT THERE WAS NO REDNESS, NO SWELLING OR ANY OTHER SIGN OF INFILTRATION/EXTRAVASATION. THE PATIENT WAS BROUGHT BACK THE FOLLOWING DAY TO REPEAT THE EXAM. REPORTEDLY, FOR THE STRESS PORTION OF THE EXAM, THE SAME CARDIOGEN 82 INFUSION SYSTEM WAS USED. A DIFFERENT INTRAVENOUS SITE LOCATION (OPPOSITE ARM) WAS USED AND ALL IMAGES WERE OBTAINED WITHOUT INCIDENT AND WERE DIAGNOSTICALLY USEFUL. THE PATIENT'S OTHER ARM (THE ARM USED THE PREVIOUS DAY) WAS AGAIN EXAMINED BY THE RADIOLOGIST AND THERE WERE STILL NO SIGNS OF EXTRAVASATION. EXTRAVASATION OF RADIOPHARMACEUTICALS CAN RESULT IN SIGNIFICANT RADIATION DOSE TO UNDERLYING TISSUE AND SKIN AT LEVELS THAT CAN EXCEED RADIATION PROTECTION AND REGULATORY LIMITS. IN ADDITION, THERE ARE EXAMPLES IN THE LITERATURE WERE EXTRAVASATION OF BOTH DIAGNOSTIC AND THERAPEUTIC RADIOISOTOPES LED TO ADVERSE TISSUE REACTIONS, INCLUDING SQUAMOUS CELL CARCINOMA AND THE INJECTION SITE.* THEREFORE, BECAUSE OF SUSPECTED EXTRAVASATION, THIS CASE IS CONSERVATIVELY ASSESSED AS REPORTABLE DUE TO THE POTENTIAL INJURY TO THE PATIENT. OSBORNE D. ET AL. PATIENT-SPECIFIC EXTRAVASATION DOSIMETRY USING UPTAKE PROBE MEASUREMENTS HEALTH PHYS. 2021 MAR; 120(3): 339-343.

    Description of Event or Problem · 0

    THIS CASE DESCRIBES THE OCCURRENCE OF EXTRAVASATION AND DRUG INEFFECTIVE IN A FEMALE INPATIENT WHO UNDERWENT AN UNKNOWN DIAGNOSTIC PROCEDURE ON (B)(6) 2021 DUE TO AN UNKNOWN REASON.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS INITIALLY RECEIVED FROM A HEALTHCARE PROFESSIONAL BY BRACCO DRUG SAFETY ON 18-FEB-2021 AS A NON-VALID REPORT DUE TO LACK OF PATIENT IDENTIFIERS. ON 25-FEB-2021, ADDITIONAL INFORMATION WAS PROVIDED INCLUDING PATIENT IDENTIFIERS AND THE CASE BECAME VALID, ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THIS CASE DESCRIBES THE OCCURRENCE OF EXTRAVASATION AND DRUG INEFFECTIVE IN A FEMALE INPATIENT WHO UNDERWENT AN UNKNOWN DIAGNOSTIC PROCEDURE ON (B)(6) 2021 DUE TO AN UNKNOWN REASON. MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND ALLERGIES WERE UNKNOWN. IT WAS NOT KNOWN IF THE PATIENT RECEIVED CONTRAST IN THE PAST. ON (B)(6) 2021, FOLLOWING INTRAVENOUS (IV) ADMINISTRATION OF AN UNKNOWN DOSE OF CARDIOGEN (RUBIDIUM 82) (LOT # 09101210291) (LINKED DRUG CASE, (B)(4)) VIA CARDIOGEN 82 INFUSION SYSTEM PATIENT ADMINISTRATION SET (LOT # AND UDI # UNKNOWN), THERE WAS A PARTIAL IMAGE OBTAINED WHICH WAS GRAINY AND NOT DIAGNOSTICALLY USEFUL (DRUG INEFFECTIVE). ACCORDING TO THE RADIOLOGIST, THERE MUST HAVE BEEN A POSSIBLE EXTRAVASATION IN THE INTRAVENOUS (IV) ANTECUBITAL SITE. HOWEVER, UPON EXAM OF THE PATIENT'S INTRAVENOUS (IV) SITE WHERE THE CARDIOGEN WAS GIVEN (REPORTER DID NOT RECALL WHICH ARM), THERE WAS NO REDNESS, NO SWELLING OR ANY OTHER SIGN OF INFILTRATION/EXTRAVASATION AT THE SITE OF INFUSION. THE PATIENT DID NOT COMPLETE THE EXAM AND WAS SENT BACK TO THE FLOOR ON (B)(6) 2021, THE PATIENT WAS BROUGHT BACK FOR THE STRESS PORTION OF THE EXAM, THE REPORTER STATED THE SAME CARDIOGEN (RUBIDIUM 82) (LOT #: 09101210291) WAS USED. AN UNKNOWN DOSE OF CARDIOGEN WAS ADMINISTERED IN A DIFFERENT INTRAVENOUS (IV) SITE LOCATION, ALL IMAGES WERE OBTAINED WITHOUT INCIDENT AND WERE DIAGNOSTICALLY USEFUL. THE PATIENT WAS ALSO EXAMINED AGAIN BY THE RADIOLOGIST AND THERE WERE NO SIGNS OF EXTRAVASATION AT THE INJECTION SITE FROM THE PREVIOUS EXAM ON (B)(6) 2021. NO TREATMENTS WERE PRESCRIBED OR GIVEN. NO FURTHER INFORMATION WAS AVAILABLE FOR THIS REPORT. THIS CASE IS MEDICALLY CLOSED WITH THE INFORMATION AT HAND. WORLD WIDE ID#: (B)(4). BRACCO COMMENT: A FEMALE INPATIENT UNDERWENT AN UNKNOWN DIAGNOSTIC PROCEDURE WITH CARDIOGEN 82 INFUSION SYSTEM DUE TO AN UNKNOWN REASON. FOLLOWING INTRAVENOUS ADMINISTRATION OF AN UNKNOWN DOSE OF CARDIOGEN (RUBIDIUM 82) VIA THE CARDIOGEN 82 INFUSION SYSTEM PATIENT ADMINISTRATION SET, REPORTEDLY, ONLY A PARTIAL IMAGE WAS OBTAINED WHICH WAS GRAINY AND NOT DIAGNOSTICALLY USEFUL (DRUG INEFFECTIVE). SUSPECTING EXTRAVASATION, THE INJECTION SITE WAS EXAMINED BUT THERE WAS NO REDNESS, NO SWELLING OR ANY OTHER SIGN OF INFILTRATION/EXTRAVASATION. THE PATIENT WAS BROUGHT BACK THE FOLLOWING DAY TO REPEAT THE EXAM. REPORTEDLY, FOR THE STRESS PORTION OF THE EXAM, THE SAME CARDIOGEN 82 INFUSION SYSTEM WAS USED. A DIFFERENT INTRAVENOUS SITE LOCATION (OPPOSITE ARM) WAS USED AND ALL IMAGES WERE OBTAINED WITHOUT INCIDENT AND WERE DIAGNOSTICALLY USEFUL. THE PATIENT'S OTHER ARM (THE ARM USED THE PREVIOUS DAY) WAS AGAIN EXAMINED BY THE RADIOLOGIST AND THERE WERE STILL NO SIGNS OF EXTRAVASATION. EXTRAVASATION OF RADIOPHARMACEUTICALS CAN RESULT IN SIGNIFICANT RADIATION DOSE TO UNDERLYING TISSUE AND SKIN AT LEVELS THAT CAN EXCEED RADIATION PROTECTION AND REGULATORY LIMITS. IN ADDITION, THERE ARE EXAMPLES IN THE LITERATURE WERE EXTRAVASATION OF BOTH DIAGNOSTIC AND THERAPEUTIC RADIOISOTOPES LED TO ADVERSE TISSUE REACTIONS, INCLUDING SQUAMOUS CELL CARCINOMA AND THE INJECTION SITE.* THEREFORE, BECAUSE OF SUSPECTED EXTRAVASATION, THIS CASE IS CONSERVATIVELY ASSESSED AS REPORTABLE DUE TO THE POTENTIAL INJURY TO THE PATIENT. *OSBORNE D. ET AL. PATIENT-SPECIFIC EXTRAVASATION DOSIMETRY USING UPTAKE PROBE MEASUREMENTS HEALTH PHYS. 2021 MAR; 120(3): 339-343.

    Description of Event or Problem · 1

    THIS CASE DESCRIBES THE OCCURRENCE OF EXTRAVASATION AND DRUG INEFFECTIVE IN A FEMALE INPATIENT WHO UNDERWENT AN UNKNOWN DIAGNOSTIC PROCEDURE ON (B)(6) 2021 DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456147 CARDIOGEN 82 INFUSION SYSTEM CARDIOGEN 82 INFUSION SYSTEM OIP 510 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 CARDIOGEN ACCESSORY TRAY 001510 & ADMIN SET 001506