HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2023-04589
- Event Type
- Malfunction
- Date Received
- November 27, 2023
- Date of Event
- November 21, 2023
- Report Date
- June 18, 2024
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION HAS BEING RECEIVED FOR THIS EVENT AND SECTIONS HAVE BEEN UPDATED. ADDITIONAL PRODUCT: HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-JUN-2024 SERIAL OR LOT#:(B)(6) UDI #: (B)(4) H4: MFG. DATE:16-JUN-2023 HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-JUN-2024 SERIAL OR LOT#:(B)(6) UDI #: (B)(4) H4: MFG. DATE:16-JUN-2023 HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-JUN-2024 SERIAL OR LOT#:(B)(6) UDI #: (B)(4) H4: MFG. DATE:16-JUN-2023 HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-JUN-2024 SERIAL OR LOT#:(B)(6) UDI #: (B)(4) H4: MFG. DATE:16-JUN-2023 HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-JUN-2024 SERIAL OR LOT#:(B)(6) UDI #: (B)(4) H4: MFG. DATE:16-JUN-2023 HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-JUN-2024 SERIAL OR LOT#:(B)(6) UDI #: (B)(4) H4: MFG. DATE:16-JUN-2023 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. 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION SUMMARY. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) ((B)(6)), THE CONTROLLER ((B)(6)), AND SIX (6) BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED CONSISTENT INCREASES IN POWER CONSUMPTION AND ESTIMATED FLOWS TO PARAMETERS ABOVE NORMAL OPERATING RANGE THROUGHOUT THE ANALYZED PERIOD; HOWEVER, NO HIGH WATT ALARMS WERE LOGGED WITHIN THE ANALYZED PERIOD. LOG FILE ANALYSIS ALSO REVEALED MOTOR START EVENTS RECORDED ON (B)(6) 2022 AT 08:52:46, ON (B)(6) 2022 AT 16:38:18, ON (B)(6) 2023 AT 15:45:57, ON (B)(6) 2023 AT 22:04:47, ON (B)(6) 2023 AT 21:47:25, AND ON (B)(6) 2023 AT 21:15:38 IN WHICH THE MOTOR START PARAMETERS WERE ATYPICAL. ADDITIONALLY, REVIEW OF THE ALARM LOG FILE REVEALED MULTIPLE CRITICAL BATTERY ALARMS LOGGED WITH A BATTERY RELATIVE STATE OF CHARGE (RSOC) VALUE OF 101% AND INCORRECT DATE/TIMESTAMPS WITH NO SERIAL NUMBER ID OR CYCLE COUNT, INDICATING THAT THE CONTROLLER WAS UNABLE TO RECOGNIZE THE CONNECTED BATTERIES. OF NOTE, THE CRITICAL BATTERY ALARM IS A HIGH PRIORITY ALARM WHICH PRODUCES A LOUD SOUND. THE CRITICAL BATTERY ALARMS LIKELY CORRESPOND WITH THE REPORTED ¿UNKNOWN ALARM¿ EVENT. REVIEW OF THE DATA LOG FILE ALSO REVEALED MULTIPLE DATA POINTS LOGGED WITH A BATTERY RSOC VALUE OF 0% WITH INCORRECT DATE/TIMESTAMPS AND NO SERIAL NUMBER IDS OR CYCLE COUNTS, INDICATING THAT THE CONTROLLER WAS UNABLE TO RECOGNIZE THE CONNECTED BATTERIES. THE INABILITY OF THE CONTROLLER TO RECOGNIZE THE BATTERIES IS LIKELY RELATED TO THE REPORTED COMMUNICATION ISSUES EVENT. CONSIDERING THAT THE CONTROLLER WAS UNABLE TO RECOGNIZE THE CONNECTED BATTERIES, THE BATTERY INDICATOR ON THE CONTROLLER¿S FRONT PANEL WOULD NOT ILLUMINATE. FURTHERMORE, REVIEW OF THE EVENT LOG FILE REVEALED MULTIPLE EVENT EXCEPTIONS WHERE THE CONTROLLER WAS RESETTING WITH INCORRECT DATE/TIMESTAMPS AND NO BATTERY SERIAL NUMBER IDS OR CYCLE COUNTS LOGGED. THE CORRUPTED DATA ENTRIES ON EACH OF THE LOG FILES HAD A TIME STAMP OF (B)(6) 1999 AT 00:00:00. INFORMATION IN AUTOLOGS REPORTS IS BASED ON THE DATA AVAILABLE IN THE CONTROLLER LOG FILES. IT IS LIKELY THAT THE INVALID DATE ENTRIES RECORDED IN THE LOG FILES AFFECTED THE ABILITY TO GENERATE AUTOLOGS REPORTS. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ABOVE NORMAL POWER CONSUMPTION EVENT, INCLUDING BUT NOT LIMITED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION, PATIENT RELATED FACTORS, AND/OR INAPPROPRIATE PUMP ROTATIONAL SPEED. BASED ON A HISTORICAL REVIEW OF SIMILAR EVENTS, 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. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED REAL TIME CLOCK ISSUE, INABILITY OF THE CONTROLLER TO RECOGNIZE THE BATTERIES, INABILITY TO GENERATE A REPORT, AND CRITICAL BATTERY ALARMS, AS WELL AS THE OBSERVED ABNORMAL BATTERY RSOC VALUES AND EVENT EXCEPTIONS, CAN BE ATTRIBUTED TO A DAMAGED INTEGRATED CIRCUIT (IC) ON THE CONTROLLER'S COMMUNICATION LINE. THE IC IS RESPONSIBLE FOR THE COMMUNICATION BETWEEN THE CONTROLLER AND BATTERIES AND IS ALSO CONNECTED TO THE REAL TIME CLOCK. THE DAMAGED IC LIKELY PREVENTED THE CONTROLLER FROM DETERMINING THE CAPACITY OF BATTERIES, THEREFORE CAUSING THE CONTROLLER TO TRIGGER CRITICAL BATTERY ALARMS AND LOG ABNORMAL RSOC VALUES. A POSSIBLE ROOT CAUSE OF THE DAMAGED IC ON THE COMMUNICATION LINE CAN BE ATTRIBUTED TO A VOLTAGE SPIKE ON THE COMMUNICATION PIN OF THE CONNECTOR. CAPA PR00465502 WAS OPENED TO INVESTIGATE THIS ISSUE. H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. ADDITIONAL PRODUCTS: D1: CONTROLLER D4: (B)(6) H3: YES D1: BATTERY D4: (B)(6) H3: YES D1: BATTERY D4: (B)(6) H3: YES D1: BATTERY D4: (B)(6) H3: YES D1: BATTERY D4: (B)(6) H3: YES D1: BATTERY D4: (B)(6) H3: YES D1: BATTERY D4: (B)(6) H3: YES H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. 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.
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCT: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER 2.0 D4: MODEL #: 1420/ CATALOG #:1420/ EXPIRATION DATE: 31-OCT-2019/ SERIAL OR LOT#: CON (B)(4) UDI #: (B)(4) H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D9: NO H4: MFG DATE: 11-OCT-2018 H5: NO HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-OCT-2018 SERIAL OR LOT#: UDI #: UNK D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H5: NO HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-OCT-2018 SERIAL OR LOT#: UDI #: UNK D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H5: NO HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-OCT-2018 SERIAL OR LOT#: UDI #: UNK D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H5: NO HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-OCT-2018 SERIAL OR LOT#: UDI #: UNK D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H5: NO HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-OCT-2018 SERIAL OR LOT#: UDI #: UNK D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H5: NO HEARTWARE VENTRICULAR ASSIST SYSTEM -:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-OCT-2018 SERIAL OR LOT#: UDI #: UNK D9: NO H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H5: NO H6: THE CODES PRESENT IN SECTION H6 CORRESPOND TO COMPONENTS/PRODUCTS THAT COMPRISE THE REPORTED EVENT. 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.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WAS HOSPITALIZED AS A RESULT OF A SCHEDULED SURGERY FOR A HERNIA. DURING HOSPITALIZATION THE CONTROLLER EXHIBITED AN UNKNOWN ALARM. THE ALARM QUICKLY VANISHED FROM THE SCREEN, MAKING IT IMPOSSIBLE TO READ. FURTHERMORE, THE CONTROLLER'S RIGHT SIDE LIGHT APPEARED DARK, AS THOUGH IF THE BATTERY WAS NOT RECOGNIZED BY THE CONTROLLER, THE ALERT STOPPED WHEN THE AC ADAPTOR WAS PLUGGED. DATA FROM THE LOG FILE ANALYSIS SHOWED THAT THE VAD POWER WAS HIGHER THAN USUAL AND THAT THERE WERE MULTIPLE MOTOR START EVENTS WITH PARAMETERS THAT WEREN'T WITHIN THE PREDICTED RANGE. THE RECORD ALSO SHOWED COMMUNICATION ISSUES AND CRITICAL BATTERY ALARMS. NO REPORTS COULD BE GENERATED, DATA ISSUE WAS REVEALED. IT WAS NOTED THAT DATA WAS CORRUPTED WITH THE YEAR 2099. THE VAD REMAINS IN USE, THE CONTROLLER , BATTERIES AND AC ADAPTER WERE EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229250 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization |