BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS GP PLUS

    MDR report key: 10703536 · Received October 20, 2020

    Report

    Report Number
    9616066-2020-20123
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 12, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALARIS GP PLUS HAD AIR BUBBLES AND THE PATIENT HAD A STROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE CURRENTLY HAVE THREE PATIENTS WHO HAVE SUFFERED A STROKE AFTER AN ELECTROPHYSIOLOGICAL EXAMINATION. WE HAVE NOTICED THAT AIR BUBBLES ARE FORMING IN THE INFUSOMAT SET. DESPITE PROPER VENTILATION. WITH THIS SYSTEM, A 500 ML NACL 0.9% INFUSION IS FLUSHED WITH 1000 IU HEPARIN. DURING AN ELECTROPHYSIOLOGICAL EXAMINATION, THE INFUSOMAT SET WAS CHECKED EVERY 10 MINUTES. AFTER A SHORT TIME, AIR BUBBLES FORM IN THE SYSTEM THAT ARE NOT DETECTED BY THE INFUSOMAT SENSOR. THE AIR ALARM LIMIT ON THESE DEVICES IS SET TO 500L. THE STATION HAS NOW RECEIVED RENTAL DEVICES IN WHICH THE DATA SET WAS SET TO 50. REPORTER: I HAVE JUST PHONED THE USER. THEY DO NOT USE A FILTER DURING THE INFUSION. AND THE FLOW RATE IN THE INCIDENTS WAS 60 ML / H AND 180 ML / H. IN TERMS OF URGENCY, I WILL NOW GIVE THE CUSTOMER THE RECOMMENDATION ACCORDING TO OUR GP OPERATING INSTRUCTIONS THAT A FILTER SHOULD BE USED. (60033E) (B)(6): PATIENTS IN THE EPU (HEART CAT LABORATORY) WE HAD THREE PATIENTS IN THE LAST WEEKS WHO DEVELOPED A MULTISYMBOLIC STROKE AFTER AN ELECTROPHYSIOLOGICAL EXAMINATION. FORTUNATELY, IN ALL CASES, THE CLINICAL SYMPTOMS RECEDED AFTER A FEW DAYS, BUT THE STROKE IS DETECTABLE ON MRI. PATIENT 1 WAS EXAMINED IN HKL 1 (EPU2) DUE TO ATYPICAL ATRIAL FLUTTER WITH THE RHYTHMIA SYSTEM USING THE ORION CATHETER. AT THE END OF THE EXAMINATION, A SLIGHT MOTOR APHASIA AND A CENTRAL FACIAL PARESIS ON THE RIGHT SIDE WERE NOTICEABLE. PATIENT 2 WAS EXAMINED IN HKL 3 (EPU1) DUE TO ATRIAL FIBRILLATION WITH THE CARTO SYSTEM USING THE PANTARAY CATHETER. SHE DEVELOPED ATAXIC HEMISY SYMPTOMS OF THE LEFT ARM ON THE EVENING OF THE EXAMINATION. PATIENT 3 WAS EXAMINED IN HKL 1 (EPU2) DUE TO ATRIAL FIBRILLATION WITH THE POLARX CRYO BALLOON. AT THE END OF THE EXAMINATION HE HAD LEFT ARM AND LEG HEMIPLEGIA. ALL PATIENTS HAD IN COMMON THAT THEY NEEDED A LONG SHEATH IN THE LEFT ATRIUM (DIFFERENT SHEATHS) THROUGH WHICH THE ORION/PENTARAY/POLARX BALLOON WAS INSERTED. TO PREVENT BLOOD CLOTS FROM FORMING, THE AIRLOCKS ARE CONTINUOUSLY FLUSHED WITH NACL+HEPARIN. THE RINSING WAS PERFORMED VIA THE CAREFUSION ALARIS GP PLUS SYSTEM (HVAC 3: MT 06228E; HVAC 1: MT02996E + INFUSION SET: GP VOLUMENTRIC PUMP / SAFETY CLAMP REF: 60593, LOT 1015131). DUE TO THESE INCIDENTS, WE CHECKED THE ALARIS GP PLUS SYSTEM + INFUSION SET IN ANOTHER PATIENT AND OPENED THE SYSTEM EVERY 10MIN TO CHECK FOR AIR BUBBLES. THIS SHOWED THAT A SPONTANEOUS FORMATION OF AIR BUBBLES BELOW THE AIR BUBBLE SENSOR OCCURS. THE AIR BUBBLES WERE REMOVED AND 10 MINUTES LATER THEY WERE DETECTED AGAIN. IN THE CASE OF UNDETECTED AIR BUBBLES, IT IS CONCEIVABLE THAT THESE COULD CAUSE MICROEMBOLISM IN THE PATIENT'S BRAIN, WHICH WOULD BE COMPATIBLE WITH THE CLINICAL SYMPTOMS. OF COURSE, THERE MAY BE OTHER REASONS FOR A STROKE DURING SUCH A PROCEDURE, BUT AIR BUBBLES IN THE LEFT HEART ARE SPECIAL RISK. AFTER REPORTING THE INCIDENTS TO THE MEDICAL TECHNOLOGY DEPARTMENT, NEW EQUIPMENT ON LOAN FROM THE COMPANY WAS IMMEDIATELY PROVIDED. DSS HK-LABORATORY HAS TESTED THE DEVICE ALARIS GP PLUS GUARDRAILS (MT 02996E) WITHOUT PATIENT IN THE ABOVE MENTIONED WAY AND FOUND THE SAME PROBLEM. THE INFUSION SET WAS THE SAME AS ABOVE WHEN TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167538 ALARIS GP PLUS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention