BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA TPE SET

    MDR report key: 2618997 · Received June 11, 2012

    Report

    Report Number
    1722028-2012-00355
    Event Type
    Death
    Date Received
    June 11, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 15, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK020041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE OPERATOR DETERMINED THAT DURING DIALYSIS PROCEDURES THIS PT'S BLOOD PRESSURE NORMALLY RUNS BETWEEN 85 AND 100 SYSTOLIC, AND THEY CONSIDER IT LOW IF THE SYSTOLIC DROPS BELOW 70. A SERVICE CALL WAS PLACED FOR THE EQUIPMENT. NO PROBLEMS WERE FOUND DURING CHECK OUT OF THE MACHINE. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. IN A CONVERSATION WITH THE PATIENT'S DOCTOR, IT WAS DETERMINED THAT THE PATIENT, PRIOR TO THE TPE, HAD WORSENING OF CARDIO AND RENAL STATUS, HAD A HISTORY OF CONGESTIVE HEART FAILURE AND WAS A HIGH MEDICAL RISK PATIENT IN GENERAL. SHE WAS NOT RESPONDING TO OTHER TREATMENTS (IE: STEROIDS) AND HER PLATELET COUNT WAS DROPPING. THE MEDICAL STAFF BEGAN TO SUSPECT THAT SHE HAD TTP. SHE WAS ALSO EXPERIENCING MENTAL STATUS CHANGES ALONG WITH THE PLATELET COUNT DROP, SO A TPE PROCEDURE WAS ORDERED. IN A CONVERSATION WITH THE PATIENT'S SURGEON, HE DID NOT FEEL THAT THE TPE WOULD HAVE BEEN RELATED TO THE PATIENT'S DEATH, BUT RECOMMENDED CONTACTING THE HEMATOLOGIST / ONCOLOGIST / NEPHROLOGIST FOR THIS PATIENT TO CONFIRM. MULTIPLE ATTEMPTS TO GET INTO CONTACT WITH THIS PHYSICIAN HAVE BEEN UNSUCCESSFUL AT THIS TIME. IF FURTHER INFORMATION IS RECEIVED FROM THIS PHYSICIAN, FOLLOW-UP INFORMATION WILL BE PROVIDED. NO AUTOPSY WAS PERFORMED ON THIS PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: THE DEVICE HISTORY RECORD WAS REVIEWED. NOTHING WAS FOUND THAT WAS RELATED TO THIS EVENT. THE OPERATOR STATED THAT THERE WAS ONE PLASMA LINE CONTAMINATION MESSAGE DURING THE PROCEDURE. SHE INCREASED THE HEMATOCRIT BY 3% AND THE RED BLOOD CELLS IN THE PLASMA LINE CLEARED. THE CBC DRAWN ON THE PATIENT WAS PRE-DIALYSIS, SO THE HEMATOCRIT USED MAY NOT HAVE BEEN FULLY ACCURATE. A SERVICE CALL WAS PLACED ON THE DEVICE. NO ISSUES WERE FOUND AND THE MACHINE WAS FUNCTIONING AS INTENDED. THE CUSTOMER PERFORMED THEIR OWN INTERNAL INVESTIGATION AND DETERMINED THAT THE CAUSE OF THE DEATH WAS DUE TO THE PATIENT'S UNDERLYING DISEASE STATE. A STATEMENT ABOUT THE CAUSE OF DEATH COULD NOT BE OBTAINED FROM THE HOSPITAL. ROOT CAUSE: BASED ON THE CUSTOMER'S INTERNAL INVESTIGATION, THE PATIENT'S UNDERLYING DISEASE STATE WAS THE CAUSE OF DEATH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT WAS UNDERGOING THE FIRST THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE FOR NEWLY DIAGNOSED THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP). SHE HAD DIALYSIS THAT MORNING PRIOR TO THE TPE PROCEDURE. HER BLOOD PRESSURE DID DROP TO 89 SYSTOLIC AND THE OPERATOR GAVE HER A BOLUS OF 100 ML OF 0.9% NORMAL SALINE AND INCREASED THE FLUID BALANCE FROM 93% TO 100%. THE PT'S BLOOD PRESSURE CAME UP TO 95 SYSTOLIC AND THEY COMPLETED THE PROCEDURE WITHOUT FURTHER PROBLEMS. THROUGHOUT THE ENTIRE PROCEDURE AND RINSEBACK THE OPERATOR STATES THAT THE PT WAS RESPONSIVE AND DENIED SYMPTOMS RELATED TO CITRATE. THE PT RECEIVED 1 GRAM OF CALCIUM GLUCONATE OVER THE COURSE OF THE PROCEDURE PROPHYLACTICALLY. WHEN THE OPERATOR WAS DISCONNECTING THE PT SHE NOTED THAT THE PT WAS UNRESPONSIVE. SHE PUT THE HEAD OF THE BED DOWN, CONTACTED THE PT'S PRIMARY NURSE AND THE PHYSICIAN AS SHE WAS NOT ABLE TO FIND A PULSE ON THE PT. CPR WAS INITIATED AND THE PT WAS GIVEN MEDICATIONS PER THE CODE TEAM. THE OPERATOR DID NOT KNOW WHAT MEDICATIONS WERE GIVEN. SHE DID NOTE THAT DURING THE RESUSCITATION EFFORTS THE PT WAS HAVING PROFUSE BLEEDING FROM THE MOUTH AND NOSE. AFTER 25 MINUTES OF RESUSCITATION THE PT DIED. IT IS UNK AT THIS TIME IF THE DEATH WAS PROCEDURE/PRODUCT-RELATED. TERUMO BCT IS AWAITING AUTOPSY RESULTS OF THE PT. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED THE KIT. THIS REPORT IS BEING FILED DUE TO A PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA TPE SET SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTI LKN TERUMO BCT 03U15296

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other