BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

    MDR report key: 20404147 · Received October 8, 2024

    Report

    Report Number
    3013428851-2024-00116
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 8, 2024
    Manufacturer
    MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS AN MDR DUE TO THE REPORTABLE MALFUNCTION OF THE CLOT OBSERVED IN THE CELLEX KIT'S RETURN LINE. SINCE THIS REPORTABLE MALFUNCTION IS ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE CELLEX KIT. A BATCH RECORD REVIEW FOR KIT LOT N302 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT N302 SHOWS NO TRENDS. THE MOST LIKELY ROOT CAUSE FOR THE ALARM #17: RETURN PRESSURE AND ALARM #18: SYSTEM PRESSURE ALARMS WERE THE CLOTS FOUND WITHIN THE CELLEX KIT'S CENTRIFUGE BOWL, RETURN BAG AND RETURN LINE. THE ROOT CAUSE FOR THE CLOT OBSERVED WITHIN THE KIT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. HOWEVER, THE CUSTOMER STATED THAT THE INCREASE IN THE DOSE OF THE PATIENT'S CALCIUM DRIP AS WELL AS THE CHANGE IN THE ECP TREATMENT PROCEDURE'S ACDA RATIO LIKELY CONTRIBUTED TO THE CLOTTING SEEN WITHIN THE CELLEX KIT. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, ALARM #18: SYSTEM PRESSURE, ALARM #17: RETURN PRESSURE, AND CLOT OBSERVED. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. PER THE CELLEX OPERATOR'S MANUAL SECTION 2-9, ANTICOAGULATION, THE ANTICOAGULANT USED IN THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM IS A HEPARINIZED SALINE SOLUTION. THE UNITS OF HEPARIN/500 ML OF 0.9% NORMAL SALINE MAY NEED TO BE ADJUSTED TO THE BODY WEIGHT OF THE PATIENT. CAUTION: INDIVIDUAL PATIENTS MAY REQUIRE A HEPARIN DOSAGE THAT VARIES FROM THE RECOMMENDED DOSE TO PREVENT POST-TREATMENT BLEEDING OR CLOTTING DURING A TREATMENT. THE CLINICIAN SHOULD REVIEW THE PATIENT'S MEDICAL CONDITION, MEDICATIONS AND PLATELET COUNT AT THE TIME OF TREATMENT AND USE CLINICAL JUDGMENT TO ESTABLISH THE OPTIMAL HEPARIN DOSAGE FOR EACH PATIENT. THIS INVESTIGATION IS NOW COMPLETE. (B)(4) S.K. 08-OCT-2024.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED MALLINCKRODT TO REPORT BLOOD CLOTTING IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER STATED THAT ACDA AT A RATIO OF 8:1 WAS THE ANTICOAGULANT THAT WAS USED DURING THE PATIENT'S ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT WAS ALSO RECEIVING A CALCIUM DRIP, 0.5 GM/HR, DELIVERED VIA THE CELLEX INSTRUMENT'S RETURN LINE DURING THE PATIENT'S ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT CALCIUM IS NORMALLY DELIVERED VIA THE CELLEX INSTRUMENT'S RETURN LINE DURING ECP TREATMENT PROCEDURES THAT USE ACDA AS THE ANTICOAGULANT. THE CUSTOMER REPORTED THAT AT 100MLS OF WHOLE BLOOD PROCESSED (WBP) THE PATIENT BEGAN TO COMPLAIN OF PARESTHESIA. THE CUSTOMER STATED THAT THEY THEN PAUSED THE PATIENT'S ECP TREATMENT PROCEDURE AND ORAL TUMS WAS GIVEN TO THE PATIENT. THE CUSTOMER REPORTED THAT THEY ALSO INCREASED THE PATIENT'S CALCIUM DRIP FROM 0.5 GM/HR TO 1.0 GM/HR. IN ADDITION, THE CUSTOMER STATED THAT A SERUM IONIZED CALCIUM LEVEL WAS DRAWN, WHICH INDICATED THE PATIENT'S BLOOD CALCIUM LEVEL WAS 1.05MG/DL. THE CUSTOMER REPORTED THAT THEY THEN CHANGED THE ECP TREATMENT PROCEDURE'S ACDA RATIO FROM 8:1 TO 10:1. THE CUSTOMER STATED THAT PRIOR TO RESTARTING THE PATIENT'S ECP TREATMENT PROCEDURE, THEY TOOK THE PATIENT'S VITALS WHICH INDICATED THAT THE PATIENT WAS EXPERIENCING HYPOTENSION. THE CUSTOMER REPORTED THAT THE PATIENT'S BLOOD PRESSURE BEFORE THEIR ECP TREATMENT PROCEDURE WAS 99/65MMHG AND 80/57MMHG AT THE TIME OF THE EVENT. THE CUSTOMER STATED THAT THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OF HYPOTENSION. THE CUSTOMER REPORTED THAT THEY THEN ATTEMPTED TO ADMINISTER A SALINE BOLUS TO THE PATIENT VIA THE CELLEX INSTRUMENT; HOWEVER, RECURRING ALARM # 17: RETURN PRESSURE ALARMS OCCURRED AND THE SALINE BOLUS, 100MLS, HAD TO BE ADMINISTERED TO THE PATIENT THROUGH A SEPARATE LINE VIA THE PATIENT'S PORT. THE CUSTOMER STATED THAT THE PATIENT'S BLOOD PRESSURE WAS 99/61MMHG FOLLOWING THE SALINE BOLUS. THE CUSTOMER REPORTED THAT THEY THEN RESUMED THE PATIENT'S ECP TREATMENT PROCEDURE AFTER THE PROCEDURE HAD BEEN PAUSED FOR AN UNKNOWN LENGTH OF TIME. THE CUSTOMER STATED THAT AT 930MLS OF WBP, THEY EXPERIENCED ALARM #18: SYSTEM PRESSURE ALARMS WHICH THEY COULD NOT RESOLVE. THE CUSTOMER REPORTED THAT THEY CHECKED THE CELLEX KIT'S RETURN BAG AND CENTRIFUGE BOWL AND DID NOT NOTICE ANY VISIBLE CLOTTING. THE CUSTOMER STATED THAT THEY THEN FLUSHED THE PATIENT'S ACCESS LINE AND TRIED TO RESUME THE PATIENT'S ECP TREATMENT PROCEDURE; HOWEVER, THE ALARM #18: SYSTEM PRESSURE ALARMS CONTINUED TO OCCUR THUS THE CUSTOMER ENDED THE PATIENT'S ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT ONCE THE CELLEX KIT'S CENTRIFUGE BOWL WAS EMPTY, THEY NOTICED CLOTS IN THE CELLEX KIT'S CENTRIFUGE BOWL, RETURN BAG, AND RETURN LINE. THE CUSTOMER STATED THAT THEY THEN ABORTED THE PATIENT'S ECP TREATMENT PROCEDURE WITH NO BLOOD RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT'S BLOOD PRESSURE WAS 102/70MMHG AT THE TIME OF THE ABORTED ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF THE ABORTED ECP TREATMENT PROCEDURE AND REQUIRED NO OTHER MEDICAL INTERVENTION AT THE TIME OF DISCHARGE. THE CUSTOMER REPORTED THAT THE PATIENT WILL CONTINUE WITH THEIR ECP TREATMENT PROCEDURES. THE CUSTOMER STATED THAT THE PATIENT'S HYPOTENSION WAS CAUSALLY RELATED TO THE PATIENT'S ECP TREATMENT PROCEDURE. HOWEVER, THE CUSTOMER REPORTED THAT THE PATIENT HAD ALSO TAKEN COLD MEDICATION PRIOR TO THEIR ECP TREATMENT PROCEDURE WHICH ALSO LIKELY CONTRIBUTED TO THE PATIENT'S HYPOTENSION. IN ADDITION, THE CUSTOMER STATED THAT THE INCREASE IN THE DOSE OF THE PATIENT'S CALCIUM DRIP AS WELL AS THE CHANGE IN THE ECP TREATMENT PROCEDURE'S ACDA RATIO LIKELY CONTRIBUTED TO THE CLOTTING SEEN WITHIN THE CELLEX KIT. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THIS MEDWATCH IS FOR THE REPORTABLE CELLEX KIT DEVICE MALFUNCTION. THE SERIOUS ADVERSE EVENTS, PARESTHESIA, HYPOCALCEMIA, AND HYPOTENSION, THAT WERE EXPERIENCED BY THE PATIENT ARE REPORTED IN MEDWATCH 3013428851-2024-00115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22984 CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM LNR MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED N302 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female