BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER

    MDR report key: 17071479 · Received June 6, 2023

    Report

    Report Number
    3007042319-2023-02353
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 30, 2023
    Report Date
    September 27, 2023
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE ANALYSIS. PRODUCT EVENT SUMMARY: THE CAC ADAPTER (B)(6) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE CAC CABLE CONNECTOR WAS NOT COMPLETELY INSERTED INTO THE AC ADAPTER RECEPTACLE AND THE BRACKET ADJUSTMENT SCREW WAS NOT COMPLETELY TIGHTENED PREVENTING THE ADAPTER FROM PROVIDING POWER. THIS OBSERVATION LIKELY TRIGGERED A POWER DISCONNECT ALARM. INTERNAL INSPECTION REVEALED NO ANOMALIES. THE CAC ADAPTER FUNCTIONED AS INTENDED AFTER CORRECTLY RECONNECTING THE CABLE CONNECTOR AND TIGHTENING THE SCREW. OF NOTE, THE CLAMP ASSEMBLY CONTAINS A SCREW THAT ENSURES THAT THE AC POWER CORD IS SECURE IN THE ADAPTER RECEPTACLE AND CANNOT BE PULLED OUT. TO ENABLE A SECURE CONNECTION, THE SCREW CAN BE LOOSENED OR TIGHTENED TO ALLOW A PROPER CONNECTION BETWEEN THE AC ADAPTER ENCLOSURE AND THE AC CORD. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO IMPROPER CONNECTION BETWEEN THE CABLE CONNECTOR AND AC ADAPTER WHICH PREVENTED THE ADAPTER FROM PROVIDING POWER AND LEADING TO POWER DISCONNECT ALARMS. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SWITCHED THE POWER SOURCE FROM THE BATTERY TO THE CONTROLLER AC (CAC) ADAPTER AND A POWER DISCONNECT LOW PRIORITY ALARM SOUNDED, AT THE TIME THE GREEN LIGHT ON THE CAC ADAPTER WAS NOT ON. THE PATIENT NOTED THAT THE CAC ADAPTER AND POWER CORD HAD POOR CONNECTION, SO THE PATIENT RECONNECTED IT AND THE CAC ADAPTER WORKED PROPERLY. AT THE HOSPITAL THE CONNECTION WAS TESTED AND THE POWER DISCONNECT ALARM SOUNDED AGAIN. THE CAC ADAPTER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570484 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 1104 VAD