BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMAFLO II

    MDR report key: 5981895 · Received September 27, 2016

    Report

    Report Number
    9616026-2016-00010
    Event Type
    Death
    Date Received
    September 27, 2016
    Date of Event
    August 28, 2016
    Report Date
    September 27, 2016
    Product Code
    KOC
    PMA / PMN Number
    K082758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMAFLO II BLOOD WARMER WAS NOT RETURNED FOR ANALYSIS. THE PRISMAFLEX CONTROL UNIT USED FOR THE CRRT TREATMENT DOES NOT OFFER MEANS OF WARMING BLOOD CIRCULATING IN THE EXTRACORPOREAL CIRCUIT. SHOULD WARMING BE CLINICALLY INDICATED AN EXTERNAL BLOOD WARMER CAN BE USED WITH THE PRISMAFLEX SYSTEM. THE PRISMAFLEX CONTROL UNIT DOES NOT HAVE ANY SUPERVISION OF EXTERNAL BLOOD WARMERS CONNECTED TO THE PRISMAFLEX SYSTEM, AS THERE IS NO COMMUNICATION BETWEEN THEM. THE TEMPERATURE OF THE HEATING PROFILE IS MONITORED BY A TEMPERATURE CONTROL SYSTEM AND BY INDEPENDENT ALARM SYSTEMS WHICH DRAW THE OPERATOR'S ATTENTION TO ALARM REACTIONS AND SWITCH OFF THE HEALING PROCESS AUTOMATICALLY IN THE EVENT OF EXCESSIVE TEMPERATURE. DURING OPERATION, THE CONTROL PANEL SHOWS THE INTERNAL TEMPERATURE OF THE HEATING PROFILE (NOT EQUAL TO THE TEMPERATURE OF THE FLUID TO BE WARMED). THIS MEANS THAT THE PRISMAFLO II DOES NOT REGULATE THE ACTUAL TEMPERATURE OF THE MEDIUM TO BE WARMED NOR DOES IT MONITOR THE TEMPERATURE. THIS TEMPERATURE IS DEPENDENT ON A VARIETY OF ADDITIONAL FACTORS (ROOM TEMPERATURE, OUTLET TEMPERATURE OF THE FLUID TO BE WARMED, FLOW RATE). MONITORING OF PATIENT CORE TEMPERATURE SHALL BE DONE BY MEDICAL STAFF. THE NEED FOR THE LATTER IS STRESSED IN THE OPERATOR'S MANUAL FOR THE PRISMAFLEX CONTROL UNIT. THE PRISMAFLEX CONTROL UNIT ((B)(4)) WAS INSPECTED AFTER THE REPORTED EVENT AND WAS FOUND TO BE WORKING WITHIN MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    A PATIENT IN THE PICU HOSPITALIZED FOR A MONTH HAD UNCONTROLLED SEIZURES OF UNKNOWN ORIGIN WITH OTHER DEBILITATING MEDICAL ISSUES INCLUDING HYPOTHERMIA. REPORTEDLY, THE PATIENT'S TEMPERATURE AT ONE POINT DURING THE HOSPITALIZATION AND PRIOR TO CRRT WAS DOWN TO 33.8 C. SHE WAS ON A BAIR HUGGER AND A WARMING PAD. THE PATIENT BECAME OLIGURIC AND BEGAN CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) UTILIZING A PRISMAFLO II BLOOD WARMER. AT THE BEGINNING OF CRRT THE PATIENT'S TEMPERATURE WAS 36.10 C (AXILLARY) AND THE BLOOD WARMER WAS SET TO 41.0 C. TWO HOURS LATER THE PATIENT'S TEMPERATURE HAD DECREASED AND THE BLOOD WARMER WAS INCREASED TO 43.0 C; THE WARMER REGISTERED 42.6 C. SEVEN HOURS INTO TREATMENT THE PATIENT SHOWED SIGNS OF INCREASING HYPOTHERMIA WITH A DECREASED HEART RATE. AT SOME POINT, THE PATIENT FLUID REMOVAL RATE WAS SET TO ZERO. THE PRISMAFLEX BLOOD FLOW RATE WAS SET AT 50 ML/MIN AND REMAINED AT THIS RATE THROUGHOUT TREATMENT. CRRT WAS TERMINATED APPROXIMATELY 15 HOURS AFTER IT WAS INITIATED DUE TO ONGOING HYPOTHERMIA. TWO HOURS AFTER TERMINATING CRRT THE PATIENT'S BODY TEMPERATURE BEGAN TO INCREASE. AN HOUR LATER THE PATIENT CODED. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. AN AUTOPSY WAS NOT PERFORMED AT THE FAMILY'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632804 PRISMAFLO II BLOOD WARMER KOC 113282

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Death PRISMAFLEX| PRISMAFLEX M 60