BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAKOS CELLEX PHOTPHERESIS SYSTEM

    MDR report key: 2960520 · Received February 12, 2013

    Report

    Report Number
    2523595-2013-00008
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P960003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATCH RECORD REVIEW FOR THE DEVICE SHOWED THAT THE PRODUCT MET RELEASE REQUIREMENTS. THE BATCH RECORD REVIEW FOR UVADEX IS STILL PENDING. MEDICAL AFFAIRS ASSESSMENT TO DATE: BASED ON THE AVAILABLE INFORMATION, THE EVENT HAS BEEN ASSESSED AS SERIOUS, EXPECTED AND RELATED TO BOTH THE DRUG AND DEVICE. (B)(4). THE NURSE REPORTED THAT THE PATIENT WAS CURRENTLY TAKING THE FOLLOWING LIST OF MEDICATIONS: ALBUTEROL SULFATE, ZELEXA, PEMOBATE, FLEXERIN, NEUROTIN, ADAVAN, SYTHROID, MIRTAZAPIN, MS CONTIN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS VOMITING WHILE BLOOD/PRODUCTS WERE BEING REINFUSED BACK TO THE PATIENT. THE TREATMENT WAS NOT RESTARTED. NAME AND FUNCTION OF THE COMPLAINANT: (B)(6). ISSUE STARTED ON: (B)(6) 2013. THE CUSTOMER INITIALLY CALLED TO REPORT A SYSTEM ERROR CODE 2 AND AIR DETECTOR TEST FAILED ALARMS WHICH WERE CAPTURED IN A SEPARATE COMPLAINT (B)(4). CUSTOMER STATED THAT ONCE THE PATIENT'S ACCESS LINE WAS DISCONNECTED WHILE TROUBLESHOOTING THE SYSTEM ALARMS, THE PATIENT REPORTED FEELING NAUSEOUS. THE OPERATOR REPORTED THAT SHE BEGAN THE MANUAL INFUSION PROCESS USING A TRANSFUSION FILTER SET TO RETURN BLOOD/PRODUCTS BACK TO PATIENT WITHOUT COMPLETING PHOTOACTIVATION. IT WAS DURING THIS PROCESS THAT THE PATIENT VOMITED A FEW TIMES. THE PATIENT'S PHYSICIAN WAS PRESENT AT THE TIME AND RECOMMENDED THAT SALINE BE ADMINISTERED TO THE PATIENT. OPERATOR STATED THAT THEY INFUSED 1 LITER OF FLUIDS TO THE PATIENT. THE OPERATOR STATED THAT THEY CONTINUED INFUSING THE REST OF THE BLOOD/PRODUCTS FROM WITHIN THE KIT BACK TO THE PATIENT. THE CONTENTS OF THE TREATMENT BAG, WHICH WAS UNTREATED CELLS + UVADEX, WAS RETURNED TO THE PATIENT FIRST. FIVE MINUTES LATER (ESTIMATE OF ELAPSED TIME PROVIDED BY THE OPERATOR) INTO INFUSION OF THESE CONTENTS WAS WHEN THE PATIENT STARTED VOMITING. THEY STOPPED THE RETURN OF FLUIDS FOR A FEW MINUTES AND GAVE THE PATIENT AN ELECTROLYTE SOLUTION; THE OPERATOR DID NOT SPECIFY WHAT THE SOLUTION CONSISTED OF. THE PATIENT CONTINUED TO VOMIT INTERMITTENTLY. THE CONTENTS OF THE RETURN BAG WERE INFUSED TO THE PATIENT NEXT. THE PATIENT WAS ADMITTED TO THE HOSPITAL LATER THAT DAY DUE TO VOMITING EVENT AFTER ALL THE CONTENTS WERE REINFUSED BACK TO THE PATIENT . THE ATTENDING NURSE STATED THAT SHE DOES NOT REMEMBER THE MINUTE TO MINUTE SEQUENCE OF WHAT HAD OCCURRED AS THEY WERE ATTENDING TO THE NEEDS OF THE PATIENT FIRST PRIOR TO THE REPORTING OF THE EVENT. THIS WAS THE BEST OF WHAT SHE COULD RECALL. THE NURSE ALSO ADDED THAT THE PATIENT WAS NAUSEOUS UPON ARRIVAL AND ALSO MENTIONED THAT THE PATIENT HAS KNOWN STOMACH ISSUES, BUT SHE DID NOT SPECIFY WHAT THE ISSUES WERE. CELLEX KIT: LOT A327-535, EXP: 10/01/2014 AND UVADEX: LOT A89417, EXP: 03/01/2015 WERE BOTH USED IN THIS REPORTED EVENT. THE INSTRUMENT WAS SET IN DOUBLE NEEDLE MODE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61276 THERAKOS CELLEX PHOTPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 A327-535

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization