BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 20534890 · Received October 25, 2024

    Report

    Report Number
    3007042319-2024-04708
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 10, 2024
    Report Date
    February 21, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707003261
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER D4: MODEL#: 1420 / CATALOG#: 1420 / EXPIRATION DATE: 31-OCT-2024 / SERIAL#: (B)(6) D9: NO H3: NO H4: MFG DATE: 11-OCT-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER D4: MODEL#: 1420 / CATALOG#: 1420 / EXPIRATION DATE: DD-MMM-YYYY / SERIAL#: (B)(6). D9: NO H3: NO H4: MFG DATE: DD-MMM-YYYY H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 30-SEPT-2023 / SERIAL#: (B)(6) D9: NO H3: NO H4: MFG DATE: 09-SEPT-2022 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 30-APRIL-2022 / SERIAL#:(B)(6) D9: NO H3: NO H4: MFG DATE: 15-APRIL-2021 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-AUG-2024 / SERIAL#: (B)(6) D9: NO H3: NO H4: MFG DATE: 26-AUG-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-AUG-2024 / SERIAL#: BAT987893 D9: NO H3: NO H4: MFG DATE: 28-AUG-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 31-AUG-2024 / SERIAL#:(B)(6) D9: NO H3: NO H4: MFG DATE: 28-AUG-2023 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 30-SEPT-2022 / SERIAL#: (B)(6) D9: NO H3: NO H4: MFG DATE: 21-SEPT-2021 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 30-SEPT-2023 / SERIAL#:(B)(6) D9: NO H3: NO H4: MFG DATE: 09-SEPT-2022 H5: NO D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL#: 1650 / CATALOG#: 1650 / EXPIRATION DATE: 30-SEPT-2023 / SERIAL#: (B)(6) D9: NO H3: NO H4: MFG DATE: 09-SEPT-2022 H5: NO ### 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 DEVICE EVALUATION. PRODUCT EVENT SUMMARY: TWO (2) CONTROLLERS (B)(6) AND SEVEN (7) BATTERIES (BAT(B)(6) WERE RETURNED FOR EVALUATION. THE VENTRICULAR ASSIST DEVICE (VAD) (B)(6) AND ONE (1) BATTERY (BAT(B)(6) WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED AS THE REPORTED EVENT AND ANALYSIS ARE NOT RELATED TO A MANUFACTURING OR SERVICING ISSUE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. INTERNAL INSPECTION OF THE BATTERIES DID NOT REVEAL ANY ANOMALIES. FAILURE ANALYSIS OF THE RETURNED CONTROLLERS REVEALED THAT THE DEVICES BOTH PASSED FUNCTIONAL TESTING. (B)(6) PASSED EXTERNAL VISUAL INSPECTION. VISUAL INSPECTION OF (B)(6) REVEALED CONTAMINATION WITHIN BOTH POWER PORTS AND THE SERIAL PORT. SUPPLEMENTAL TESTING WAS PERFORMED, AND THE TEST RESULTS REVEALED CONTAMINATION ON THE PINS AND THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. NO DAMAGE TO THE CONTROLLER RECEPTACLES' SPRINGS WAS OBSERVED. INTERNAL VISUAL INSPECTION REVEALED A CRACK ON STANDOFF POST ONE (1) WITHIN THE CONTROLLER HOUSING OF BOTH CONTROLLERS. THIS IS AN ADDITIONAL FINDING, NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION, THE ROOT CAUSE OF THE STANDOFF POST CRACKS WAS DETERMINED TO BE DUE TO MINERAL OIL APPLIED TO THE CONTROLLER¿S INTERNAL MAIN GASKET AND/OR TO THE SILICONE ADHESIVE APPLIED AROUND THE CONTROLLER¿S INTERNAL BATTERY COMING INTO CONTACT WITH THE STANDOFF POST. THE MINERAL OIL AND/OR SILICONE ADHESIVE CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. CAPA PR00517125 IS INVESTIGATING THIS ISSUE. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PRIMARY CONTROLLER IN USE DURING THE REPORTED EVENT. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH (B)(6) REVEALED THAT THE CONTROLLER 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 DISC CONNECTIONS INVOLVING BAT(B)(6) WITHIN THE ANALYZED PERIOD, AS WELL AS A PREMATURE POWER SWITCHING EVENT DUE TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND A BATTERY. THE ASSOCIATED BATTERIES HAD BEEN LUBRICATED PRIOR TO RELEASE. REVIEW OF THE ALARM LOG FILE DID NOT REVEAL ANY POWER DISCONNECT ALARMS LOGGED WITHIN THE ANALYZED PERIOD; HOWEVER, REVIEW OF THE DATA LOG FILE REVEALED MULTIPLE INSTANCES, INCLUDING INVOLVING BAT(B)(6), WHERE THE BATTERIES¿ RELATIVE STATE OF CHARGE (RSOC) VALUES WERE LOGGED BETWEEN 101-201, WHICH IS INDICATIVE OF COMMUNICATION ERRORS. A COMMUNICATION ERROR WILL TRIGGER A POWER DISCONNECT ALARM IF THE OTHER POWER SOURCE IS A POWER ADAPTER OR A BATTERY WITH AN RSOC GREATER THAN 25%. ADDITIONALLY, REVIEW OF THE ALARM LOG FILE REVEALED TWO (2) CRITICAL BATTERY ALARMS, LOGGED ON (B)(6)2024 AT 17:18:33 AND ON (B)(6) 2024 AT 18:20:23, DUE TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. REVIEW OF THE ALARM LOG FILE ALSO REVEALED ONE (1) HIGH WATT ALARM LOGGED ON (B)(6)2024 AT 11:01:48. HOWEVER, NO LOW FLOW ALARMS WERE LOGGED WITHIN THE ANALYZED PERIOD. ADDITIONALLY, ONE (1) VAD DISCONNECT ALARM WAS LOGGED ON (B)(6) 2024 AT 15:50:58, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DURING THE REPORTED CONTROLLER EXCHANGE. LOG FILE ANALYSIS ALSO REVEALED MOTOR START EVENTS RECORDED ON 20/AUG/2024 AT 12:34:29, ON 23/SEP/2024 AT 12:01:19, ON 13/OCT/2024 AT 20:54:16, AND ON 19/OCT/2024 AT 11:01:43 IN WHICH THE MOTOR START PARAMETERS WERE ATYPICAL. REVIEW OF THE EVENT LOG FILE REVEALED 30 CONTROLLER POWER-UP EVENTS LOGGED BETWEEN 10/SEP/2024 AT 20:39:38 AND 21/OCT/2024 AT 12:35:09, INDICATING CONTROLLER LOSSES OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE OF ABOUT 16 SECONDS. SEVERAL MOMENTARY DISCONNECTIONS WERE RECORDED LEADING UP TO SEVERAL OF THE LOSSES OF POWER. OF NOTE, FOLLOWING ONE OF THE CONTROLLER POWER-UP EVENTS ON 17/OCT/2024, THE CONTROLLER POWER DOWN TIME WAS RECORDED WITH AN INVALID TIME STAMP OF 16:45:22. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. THE POTENTIAL EXISTS FOR THE TIMESTAMP ON A POWER DOWN EVENT WRITTEN TO THE LOG FILES TO BE INACCURATE. THIS IS DUE TO THE TIMING OF OPERATIONS BY THE SOFTWARE USED TO CALCULATE THE POWER DOWN T IME. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED INVALID TIMESTAMP EVENT CAN BE ATTRIBUTED TO THE SOFTWARE DESIGN FOR CALCULATING THE POWER DOWN TIME. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS NOT IN USE WITHIN THE ANALYZED PERIOD AND WAS LIKELY THE PATIENT¿S BACKUP CONTROLLER. AS A RESULT, THE REPORTED ATYPICAL MOTOR START PARAMETERS, HIGH WATT ALARM, POWER SWITCHING, CONTROLLER LOSS OF POWER, AND POWER DISCONNECT ALARM EVENTS WERE CONFIRMED. THE REPORTED LOW FLOW EVENT COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. POSSIBLE ROOT CAUSES OF THE COMMUNICATION ERRORS, AND RESULTING POWER DISCONNECT ALARMS AND CRITICAL BATTERY ALARMS, CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERIES, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00574181, A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO A COMMUNICATION ERROR AND/OR MOMENTARY DISCONNECTIONS DUE TO FRETTING CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS AND/OR CONTAMINATION ON THE CONTROLLER RECEPTACLE SOCKETS/POWER SOURCE PINS. EVEN THOUGH THIS CAPA IS NOW CLOSED, (B)(6) AND THE ASSOCIATED BATTERIES FALL IN SCOPE OF THIS CAPA. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER EVENTS CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. CAPA PR00551638 INVESTIGATED CONTROLLER LOSSES OF POWER. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE HIGH-POWER EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION, INAPPROPRIATE PUMP ROTATIONAL SPEED, AND/OR PATIENT RELATED FACTORS. BASED ON THE RISK DOCUMENTATION, THE MOST LIKELY ROOT CAUSE OF ATYPICAL MOTOR START PARAMETERS MAY BE ATTRIBUTED, BUT NOT LIMITED, TO OUTER SHROUD CONTACT THAT CREATES MORE FRICTION AT THE HOUSING TO IMPELLER INTERFACE DURING PUMP STARTUP. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. ADDITIONAL PRODUCTS: D1: CONTROLLER D4:(B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: CONTROLLER D4: (B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6), D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6) D9: YES, RETURN DATE: 08-NOV-2024 H3: YES D1: BATTERY D4: BAT(B)(6) H3: YES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED NUMEROUS MOTOR START EVENTS WITH PARAMETERS OUTSIDE OF THE TYPICAL RANGE, ABOVE NORMAL EXPECTED RANGE, HIGH WATTS AND LOW FLOWS. IT WAS ALSO REPORTED THAT TWO CONTROLLERS AND SEVERAL BATTERIES EXHIBITED POWER SWITCHING. IT WAS NOTED THAT ONE OF THE CONTROLLERS EXHIBITED AN UNEXPECTED LOSS OF POWER, AND TWO OF THE BATTERIES EXHIBITED POWER DISCONNECT ALARMS. THE VAD AND ONE OF THE BATTERIES REMAINS IN USE, THE CONTROLLERS AND REMAINDER BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048353 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707003261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male