BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 22795306 · Received August 13, 2025

    Report

    Report Number
    3007042319-2025-01910
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    October 7, 2024
    Report Date
    October 14, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707007658
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION WAS RECEIVED. 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

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ANALYSIS AND INVESTIGATION COMPLETION. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650 / CATALOG #:1650 / EXPIRATION DATE:31-MAR-2025/SERIAL #: (B)(6)/UDI #: (B)(4), (B)(6). D9: NO. H4: MFG DATE:15-MAR-2024 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650 / CATALOG #:1650 / EXPIRATION DATE: 31-OCT-2024/SERIAL #: (B)(6)/ UDI #: (B)(4), (B)(6). D9: NO. H4: MFG DATE: 02-OCT-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #:1650/EXPIRATION DATE: 31-OCT-2024/ SERIAL #: (B)(6)/ UDI #: (B)(4), (B)(6). D9: NO. H4: MFG DATE: 02-OCT-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #:1650/ CATALOG #:1650/EXPIRATION DATE: 30-SEP-2024/ SERIAL #: (B)(6)/ UDI #:(01)00763000629717(17)240930(21)(B)(4) VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650/ EXPIRATION DATE: 31-MAR-2024/ SERIAL #: (B)(6)/ UDI #: (B)(4), (B)(6). D9: NO. H4: MFG DATE: 20-MAR-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #:1650 / EXPIRATION DATE:30-SEP-2024/SERIAL #: (B)(6)/ UDI #: (B)(4), (B)(6). D9: NO. H4: MFG DATE: 10-SEP-2023 H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. PRODUCT EVENT SUMMARY: THE CONTROLLER (B)(6) AND SIX (6) BATTERIES (B)(6) WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE DEVICES MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED TWENTY (20) CONTROLLER POWER UP EVENTS WITH ASSOCIATED MOTOR START EVENTS LOGGED BETWEEN (B)(6) 2024 AT 16:28:20 AND (B)(6) 2025 AT 19:40:03, AND BETWEEN (B)(6) 2025 AT 19:35:21 AND (B)(6) 2025 AT 20:32:24, INDICATING LOSSES OF POWER TO THE CONTROLLER. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE OF ELEVEN (11) SECONDS. NO ANOMALIES WERE LEADING TO THE LOSSES OF POWER BETWEEN (B)(6) 2025 AND (B)(6) 2025. THE CONTROLLER CAN ONLY STORE A MAXIMUM OF 30 DAYS OF DATA. AFTER REACHING THE LIMIT, THE CONTROLLER INITIATES A FIRST-IN FIRST-OUT METHOD WHEREBY THE OLDEST DATA POINT IS DELETED TO ALLOW THE NEWEST DATA POINT TO BE RECORDED. AS A RESULT, THE DATA LOG FILE COVERING THE LOSSES OF POWER BETWEEN (B)(6) 2024 AND (B)(6) 2025 WERE NOT AVAILABLE FOR ANALYSIS. LOG FILE ANALYSIS ALSO REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT, (B)(6), CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6). THE BATTERIES WERE LUBRICATED PRIOR TO RELEASE. AS A RESULT, THE REPORTED LOSS OF POWER AND POWER SWITCHING EVENTS WERE CONFIRMED. THE REPORTED CONTAMINATION EVENT COULD NOT BE CONFIRMED DUE TO INSUFFICIENT INFORMATION. A POSSIBLE ROOT CAUSE OF THE REPORTED CONTROLLER CONTAMINATION EVENT CAN BE ATTRIBUTED BUT NOT LIMITED TO THE HANDLING OF THE DEVICE. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00574181, A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO FRETTING CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS, CONTAMINATION ON THE CONTROLLER RECEPTACLE SOCKETS/POWER SOURCE PINS, AND/OR A LARGE SPRING GAP BETWEEN THE CONTROLLER RECEPTACLE SPRING AND TROUGH CAUSED BY A DAMAGED RECEPTACLE. EVEN THOUGH THIS CAPA IS NOW CLOSED, (B)(6) AND ASSOCIATED BATTERIES FALL IN SCOPE OF THIS CAPA. THE MOST LIKELY ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO THE REPORTED DISCONNECTION OF BOTH POWER SOURCES, AS DESCRIBED IN THE EVENT DETAILS. CAPA PR00551638 INVESTIGATED CONTROLLER LOSSES OF POWER. EVEN THOUGH THIS CAPA IS NOW CLOSED, (B)(6) FALLS IN SCOPE OF THIS CAPA. 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 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

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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

    IT WAS FURTHER REPORTED THAT THE LOSS OF POWER OCCURRED DUE TO A DOUBLE DISCONNECTION OF BOTH POWER SOURCES BY THE PATIENT. IT WAS ALSO REPORTED THAT THE CONTROLLER EXHIBITED POWER SWITCHING DUE TO PORT CONTAMINATION.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED PRODUCT PERFORMANCE DATA. MANUFACTURER'S ANALYSIS SUBSEQUENTLY REVEALED THAT THE CONTROLLER EXHIBITED MULTIPLE UNEXPECTED LOSSES OF POWER, THE CONTROLLER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76109 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707007658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 1104 VAD