BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 2705975 · Received August 15, 2012

    Report

    Report Number
    2523595-2012-00052
    Event Type
    Death
    Date Received
    August 15, 2012
    Date of Event
    November 21, 2011
    Report Date
    July 27, 2012
    Manufacturer
    THERAKOS
    Product Code
    LNR
    PMA / PMN Number
    P680003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT FILE FOR (B)(4) WAS PERFORMED AND SHOWED THAT THIS LOT MET ALL RELEASE REQUIREMENTS. THE KIT AND SMART CARD WAS RECEIVED AND ANALYZED. THE PERFORMANCE OF THE RETURNED KIT DID NOT INDICATE A PROBLEM WITH THE KIT. IT IS UNLIKELY THAT A PROBLEM WITH THE RETURNED KIT WAS A CAUSE OF THE ADVERSE EVENT. THERAKOS MEDICAL DOES NOT CONSIDER THE DEATH EVENT TO HAVE BEEN CAUSED OR CONTRIBUTED BY A THERAKOS PRODUCT. SINCE THE PT WAS CONNECTED TO THE DEVICE AT THE TIME OF PT BECOMING UNRESPONSIVE, THERAKOS HAS MADE THE CONSERVATIVE DECISION TO REPORT THE EVENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THERAKOS RECEIVED A REPORT FOR CARDIOPULMONARY ARREST WHILE RECEIVING ECP TREATMENT. AFTER INFUSION OF TREATED CELLS WAS COMPLETED, PT STATED SHE WAS NOT FEELING WELL. WHEN PT SAT UP, CUSTOMER NOTED PT LOOKED PALE WITH A BLOOD PRESSURE OF 114/72 AND HEART RATE OF 105. CUSTOMER TIPPED PT BACK AND ELEVATED PT'S FEET. THE PT BECAME UNRESPONSIVE. TREATMENT WAS ABORTED AND PT WAS DISCONNECTED. PT HAD AGONAL BREATHING AND A PULSE, BUT WAS INTUBATED AND BROUGHT TO THE ICU. CUSTOMER STATED PT WAS FINE DURING EVENT. CUSTOMER ALSO MENTIONED THAT PT WAS AFIB OVER THE WEEKEND, THIS WAS AN INPATIENT. CUSTOMER ALSO STATED THAT THERE WERE A FEW ALARMS DURING TREATMENT, BUT COULD NOT RECALL WHICH ONES THEY WERE . BECAUSE OF THE ALARMS, CUSTOMER LOWERED THE BOWL OPTIC SENSOR. CUSTOMER ADDED THAT WHEN TREATMENT PROCEDURE WAS AT OR CLOSE TO 1500 WBP, CUSTOMER INCREASED WBP TARGET TO 1650 TO HELP PUSH THE BUFFY. THE MORNING OF (B)(6) 2011: PT'S LAB RESULTS WERE UNREMARKABLE AND SHE UNDERWENT ECP TREATMENT WITHOUT INCIDENT OR DIFFICULTY UNTIL THE VERY END OF THE PROCEDURE WHERE THE PT STARTED TO COUGH, HAD A BP OF 140/90 AND STARTED TO BECOME PROGRESSIVELY NON-RESPONSIVE. WHEN THE PHYSICIAN ARRIVED, THE PT BECAME CYANOTIC AND PULSELESS. CPR WAS INITIATED. PT WAS BROUGHT TO ICU AND EXPIRED. PHYSICIAN STATED THAT PT DID NOT HAVE SIGNS OF SYMPTOMS OF DVT AND HAD BEEN ON LOW DOSE LMWH PROPHYLAXIS. PHYSICIAN ALSO ADDED THAT PT DID NOT APPEAR TO BE FLUID OVERLOADED PRIOR TO THE PROCEDURE. PHYSICIAN FELT THAT THE PT EXPIRED MOST LIKELY DUE TO A LARGE PULMONARY EMBOLUS BASED ON AN ECHOCARDIOGRAM WHICH SHOWED RV STRAIN WITH NORMAL LV EF. PHYSICIAN HAD DIFFICULTY OXYGENATING POST INTUBATION DUE TO THE FACT THAT PT HAD BEEN SEDENTARY FOR QUITE A WHILE. PT HAD A PRIOR EPISODE OF OVERNIGHT SHORTNESS OF BREATH THAT RESOLVED WITHOUT A SPECIFIC DIAGNOSIS. PHYSICIAN DID NOT FEEL THAT THE EPISODE WAS RELATED TO ECP, NOR TO THE EXPOSURE OF UVADEX, BASED ON THE FACT THAT THE PT TOLERATED THE PREVIOUS TREATMENTS WELL. THERE WERE NO OTHER INCIDENCES DURING THIS TREATMENT AND THERE WAS NO EVIDENCE OF SIGNIFICANT FLUID DISTURBANCES DURING THIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAKOS CELLEX PHOTOPHERESIS SYSTEM CELLEX ECP SYSTEM LNR THERAKOS 6661 Z317

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death RILUXAN| REVLIMID