BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 19836793 · Received July 26, 2024

    Report

    Report Number
    2184009-2024-00436
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 14, 2024
    Report Date
    August 22, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HMS WORKED WELL AND GAVE A HEPARIN DOSE RESPONSE. THERE WAS NO ISSUE WITH HMS. IT PROVIDED A PATH TO FOLLOW TO UNDERSTAND HOW THEY CAN THROMBOSE A CIRCUIT SO QUICKLY. THE OCTAPLEX WAS A MOLECULE TO REVERSE THE EFFECT OF THE ANTICOAGULANT THAT THE PATIENT TOOK DURING THE DAY. THEREFORE, WHEN THE OCTAPLEX WAS GIVEN TO PATIENT THE LOGIC WOULD DICTATE THAT THE PATIENT WOULD BE COAGULATED BUT THEY WERE NOT COAGULATED. THE OCTAPLEX WAS GIVEN TO THE PATIENT SHORTLY BEFORE TAKING THE SAMPLE FOR THE HDR TEST. THE OCTAPLEX SHOULD HAVE COAGULATED THE PATIENT. THEREFORE, THE HMS SHOULD HAVE GIVEN A SIGNIFICANT HEPARIN VALUE. HOWEVER, THIS WAS NOT THE CASE. THE HMS GAVE A LOW HEPARIN VALUE. THIS INDICATED THAT THE PATIENT WAS STILL ANTICOAGULATED. THIS MEANT THAT THE HMS DID NOT SEE THE EFFECTS OF THE OCTAPLEX. THE OCTAPLEX HAD A DELAYED EFFECT. IT ALSO MEANT THAT IF THEY DO NOT GIVE A VERY HIGH QUANTITY OF HEPARIN, THE COAGULANT EFFECT OF THE OCTAPLEX ARRIVING LATER, IT THROMBOSES THE CIRCUIT EVEN IF THE CLIENT GAVE MORE HEPARIN THAN THE DOSE RECOMMENDED BY THE HMS. IT WAS REPORTED THAT THIS WAS NOT ENOUGH AND MUCH MORE SHOULD HAVE BEEN GIVEN TO THE PATIENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR, IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, THE ACT WAS 456 SECONDS AND THE CUSTOMER STATED THAT THERE WAS RESISTANCE TO REACH THE FLOW, A DROP IN OXYGEN SATURATION OCCURRED AND THE OXYGENATOR WAS OBSTRUCTED. THE CUSTOMER STATED THAT THERE WAS AN INCREASE IN OXYGEN THERAPY AND GAS PERFORMANCE, WHICH CONFIRMED THE HYPOXIA OF THE OXYGENATOR DESPITE THE 100% OXYGEN. THROMBUS WAS OBSERVED IN THE OXYGENATOR. SEE THE ATTACHED PHOTOS. THE CIRCUIT WAS REPLACED DURING THE SURGERY BEFORE THE PATIENT WAS CLAMPED AND THIS RESULTED IN A DELAY IN PATIENT CARE. IT WAS STATED THAT THE DELAY IN CARE HAD NO CLINICAL CONSEQUENCES FOR THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT OCTAPLEX WAS USED BEFORE STARTING THE PROCEDURE AND THEN HEPARIN AND EXACYL WERE USED DURING THE PROCEDURE. THE TEMPERATURE OF THE ARTERIAL AND VENOUS LINE OF THE OXYGENATOR WAS 35°C. THROMBUS WAS OBSERVED IN THE AP40 CENTRIFUGAL PUMP HEAD AND OXYGENATOR. THE FIBRIN GREW SUDDENLY. AIR WAS NOT ENTERING THE RESERVOIR RELATED TO TABLE MANNERS. SUCKER BLOOD WAS NOT SEQUESTERED TO THE CELL SAVER BEFORE RETURNING TO CARDIOTOMY VENOUS RESERVOIR (CVR). THE LEVEL IN THE CVR WHEN THE ISSUE OCCURRED IS UNKNOWN. THE ARTERIAL FLOW RATE WAS 4.100L AND THE VENOUS FLOW RATE WAS 4.600L. SEE THE ATTACHED PERFUSION RECORDS. THE PATIENT HAD PREVIOUSLY BEEN ON ANTI VITAMIN K, OCTAPLEX WAS GIVEN TO REVERSE IT. HEPARIN DOSING WAS MONITORED USING A HMS PLUS. THE PATIENT'S BASAL ACT WAS 147 SECONDS. THE HMS PLUS ADVISED THAT 12512 IU OF HEPARIN WAS NEEDED, THE CUSTOMER DECIDED TO GIVE MORE AND 18000IU WAS GIVEN. THE ACT AT THE START OF THE PROCEDURE WAS 456 SECONDS AND THEN AN ADDITIONAL 2000IU OF HEPARIN WAS ADDED IN THE CIRCUIT BEFORE STARTING. THE CUSTOMER STATED THAT WHEN THEY STOPPED EXTRACORPOREAL CIRCULATION, THE ACT WAS 319 SECONDS. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THE PATIENT DID NOT HAVE HYPOXIA. THE CUSTOMER STATED THAT THE PATIENT WAS GOOD. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT SEEMED THE HMS PLUS DID NOT DETECT THE OCTAPLEX EFFECT BECAUSE IT GAVE A LOW RESULT FOR HDR (AS IF PATIENT WAS ALWAYS ANTICOAGULATED). THE OCTAPLEX EFFECT CAME AFTER AND CLOTTED THE SYSTEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HMS PLUS WAS USED AS USUAL. SEE ATTACHED PERFUSION NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485036 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown