BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 12001594 · Received June 15, 2021

    Report

    Report Number
    1220063-2021-00018
    Event Type
    Injury
    Date Received
    June 15, 2021
    Report Date
    July 23, 2021
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K113798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED FROM THE HOSPITAL STATING THAT THERE WERE SEVERAL POSSIBLE EXPLANATIONS FOR A FAILURE TO ACCURATELY MONITOR THE IBP: -A KINK OR OCCLUSION OF THE SALINE GIVING SET. -A PARTIALLY CLOSED 3 WAY TAP. -A FAILURE TO SECURELY PLUG A CABLE INTO THE PORT. THE CUSTOMER NOTES THAT THERE IS A STRONG POSSIBILITY THAT HUMAN FACTORS ARE THE MAIN CONTRIBUTING ELEMENT DUE TO THE ONGOING RESUSCITATION OF A PERI-ARREST PATIENT IN A HIGHLY STRESSED ENVIRONMENT. NO DEVICE MALFUNCTION WAS IDENTIFIED AFTER THE TESTING OF THE EQUIPMENT BY THE HOSPITAL. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED: PLEASE PROVIDE THE LOG FILES FROM THE CITED DEVICE. PLEASE PROVIDE THE PART NUMBERS OF ALL THE INVASIVE AND NON-INVASIVE BLOOD PRESSURE EQUIPMENT IN USE DURING THE EVENT. DURING THE REPORTED DISCREPANCY WHEN THE IBP WAS SHOWN TO BE LOW AND NIBP WAS SHOWN TO BE HIGH, WHAT WHERE THE APPROXIMATE VALUES OF THE IBP AND NIBP? PLEASE CLARIFY, WHERE WERE THE LEADS ON THE PRESSURE TRANSDUCER BEFORE AND AFTER THE REPORTED INACCURATE READING? WHAT WAS THE CONDITION OF THE PATIENT AFTER THE EVENT? THIS INFORMATION WAS NOT PROVIDED HOWEVER. THEREFORE, NO DEVICE MALFUNCTION COULD BE VERIFIED AND THE ROOT CAUSE OF THE REPORTED DISCREPANCY COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A YOUNG FEMALE ATTENDED THEATRE WITH SEVERE HYPOTENSION AND A SUSPECTED BLEED. CONDITION DETERIORATED, BLOOD PRESSURE THROUGHOUT WAS SHOWN AS LOW WHICH WAS IN LINE WITH THE CLINICAL PICTURE. PATIENT WAS STABILIZED DURING SURGERY. FOLLOWING SURGERY, BLOOD PRESSURE THEN DROPPED SEVERELY AND WAS TREATED WITH INOTROPES AND FLUID WITH NO RESPONSE ACCORDING TO THE INVASIVE ARTERIAL MONITORING. WHEN CHECKED WITH A NON INVASIVE METHOD, BLOOD PRESSURE WAS SHOWN TO BE SEVERELY HIGH. LEADS WERE ADJUSTED AND MOVED ON THE ARTERIAL TRANSDUCER AND THIS THEN EVENTUALLY SHOWED THE CORRECT BLOOD PRESSURE. LEADS CHECKED WITH TRUST'S EBME DEPARTMENT AND NO FAULT FOUND. INCIDENT REPORTED THROUGH TRUST STANDARD PROCESS AND INVESTIGATED. NO ADVERSE PATIENT IMPACT WAS REPORTED AS A RESULT OF THE MEDICATION INCORRECTLY BEING ADMINISTERED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A YOUNG FEMALE ATTENDED THEATRE WITH SEVERE HYPOTENSION AND A SUSPECTED BLEED. CONDITION DETERIORATED, BLOOD PRESSURE THROUGHOUT WAS SHOWN AS LOW WHICH WAS IN LINE WITH THE CLINICAL PICTURE. PATIENT WAS STABILIZED DURING SURGERY. FOLLOWING SURGERY, BLOOD PRESSURE THEN DROPPED SEVERELY AND WAS TREATED WITH INOTROPES AND FLUID WITH NO RESPONSE ACCORDING TO THE INVASIVE ARTERIAL MONITORING. WHEN CHECKED WITH A NON INVASIVE METHOD, BLOOD PRESSURE WAS SHOWN TO BE SEVERELY HIGH. LEADS WERE ADJUSTED AND MOVED ON THE ARTERIAL TRANSDUCER AND THIS THEN EVENTUALLY SHOWED THE CORRECT BLOOD PRESSURE. LEADS CHECKED WITH TRUST'S EBME DEPARTMENT AND NO FAULT FOUND. INCIDENT REPORTED THROUGH TRUST STANDARD PROCESS AND INVESTIGATED. NO ADVERSE PATIENT IMPACT WAS REPORTED AS A RESULT OF THE MEDICATION INCORRECTLY BEING ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893678 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention