HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2021-00020
- Event Type
- Death
- Date Received
- January 4, 2021
- Date of Event
- December 18, 2020
- Report Date
- May 24, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707003261
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1336-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A MAUDE REPORT. SECTION F HAS BEEN UPDATED TO REFLECT THAT REPORT. MAUDE DATABASE REPORT NUMBER: (B)(4). F7 TYPE OF REPORT: INITIAL, FOLLOWUP F8 DATE OF THIS REPORT: 06-MAY-2021, 20-APR-2021. F9 APPROXIMATE AGE OF DEVICE: F10 EVENT PROBLEM CODES: F11 REPORT SENT TO FDA: 06-MAY-2021. F12 LOCATION WHERE EVENT OCCURRED: HOSPITAL. F13 REPORT SENT TO MANUFACTURER: UNKNOWN. F14 MFR. NAME: MEDTRONIC, PLC ADDL: 14400 NW 60TH AVE CITY: MIAMI LAKES STATE: FL ZIP: 33014. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6), H6: IMG CODE(S): G04035. 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.
THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER D00595825 DUE TO AN FDA AUDIT OBSERVATION. A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL EVENT DETAILS AND DEVICE ANALYSIS. PRODUCT EVENT SUMMARY: THE PUMP (B)(6) WAS NOT RETURNED FOR EVALUATION. THE CONTROLLER (CON408686) WAS RETURNED FOR EVALUATION. V ARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED A BENT PIN WITHIN THE POWER PORT ONE (1). THE BENT PINS DO NOT ALLOW A POWER SOURCE TO CONNECT TO THE CONTROLLER. THE INABILITY TO CONNECT A POWER SOURCE RESULTED IN A POWER DISCONNECT ALARM. ADDITIONALLY, VISUAL INSPECTION REVEALED CONTAMINATION WITHIN BOTH POWER PORTS OF THE CONTROLLER. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT, LIKELY DUE TO THE HANDLING OF THE DEVICE. LOG FILE ANALYSIS REVEALED 11 CONTROLLER POWER UP EVENTS WITH ASSOCIATED MOTOR START EVENTS LOGGED ON 18-DEC-2020 BETWEEN 22:14:09 AND 22:31:40. OF NOTE, ONLY ONE (1) POWER SOURCE WAS CONNECTED TO POWER PORT ONE (1) DURING THE LOSSES OF POWER AND DIFFERENT POWER SOURCES WERE CONNECTED TO POWER PORT ONE (1) BETWEEN THE 11 CONTROLLER POWER UP EVENTS. NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSSES OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE 22 SECONDS PER LOSS OF POWER. ANALYSIS OF THE ALARM LOG FILE REVEALED 11 VAD DISCONNECT ALARMS LOGGED ON 18-DEC-2020 BETWEEN 22:15:39 AND 23:13:46, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING OF THE CONTROLLER. ADDITIONALLY, MULTIPLE CONTROLLER POWER UP EVENTS WITHOUT MOTOR START EVENTS WERE LOGGED SINCE 23:07:44, LIKELY DUE TROUBLESHOOTING OF THE CONTROLLER. IT IS LIKELY THE VAD DISCONNECT ALARM CONTRIBUTED TO THE REPORTED "UNKNOWN ALARMS". ADDITIONALLY, LOG FILES REVEALED SEVEN (7) LOW FLOW ALARMS WERE LOGGED SINCE 02-DEC-2020. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON THE ONE ATTACHED POWER SOURCE. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. THE MOST LIKELY ROOT CAUSE OF THE BENT PIN WITHIN THE POWER PORT EVENT CAN BE ATTRIBUTED TO A MISALIGNMENT BETWEEN THE POWER PORT AND A POWER SOURCE OUTPUT CONNECTOR. CAPA PR00384004 WAS OPENED TO INVESTIGATE BENT/DAMAGED PINS WITH CONTROLLER 2.0. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARM EVENT CAN BE ATTRIBUTED TO THE INABILITY TO CONNECT A POWER SOURCE TO THE CONTROLLER. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING OF THE CONTROLLER. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, INAPPROPRIATE PUMP ROTATIONAL SPEED. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS 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 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 ADDITIONAL INFORMATION. NEWLY RECEIVED INFORMATION INCLUDED DETAILS REGARDING THE ALARMS THAT OCCURRED AND THAT THE CONTROLLER WAS RETURNED. ADDITIONAL PRODUCTS: CONTROLLER 2.0 CON408686, D9: YES, RETURN DATE: 08-FEB-2021, H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES, H6: FDA DEVICE CODE(S): A0708, 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.
THIS SUPPLEMENTAL IS BEING SUBMITTED FOR COMPLETED ANALYSIS AND INVESTIGATION. PRODUCT EVENT SUMMARY: THE VAD WAS NOT RETURNED FOR EVALUATION. THE CONTROLLER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED A BENT PIN WITHIN THE POWER PORT ONE (1). THE BENT PINS DO NOT ALLOW A POWER SOURCE TO CONNECT TO THE CONTROLLER. THE INABILITY TO CONNECT A POWER SOURCE RESULTED IN A POWER DISCONNECT ALARM. ADDITIONALLY, VISUAL INSPECTION REVEALED CONTAMINATION WITHIN BOTH POWER PORTS OF THE CONTROLLER. THIS IS AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT, LIKELY DUE TO THE HANDLING OF THE DEVICE. LOG FILE ANALYSIS REVEALED 11 CONTROLLER POWER UP EVENTS WITH ASSOCIATED MOTOR START EVENTS LOGGED ON 18/DEC/2020 BETWEEN 22:14:09 AND 22:31:40. OF NOTE, ONLY ONE (1) POWER SOURCE WAS CONNECTED TO POWER PORT ONE (1) DURING THE LOSSES OF POWER AND DIFFERENT POWER SOURCES WERE CONNECTED TO POWER PORT ONE (1) BETWEEN THE 11 CONTROLLER POWER UP EVENTS. NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSSES OF POWER. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE 22 SECONDS PER LOSS OF POWER. ANALYSIS OF THE ALARM LOG FILE REVEALED 11 VAD DISCONNECT ALARMS LOGGED ON 18/DEC/2020 BETWEEN 22:15:39 AND 23:13:46, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING OF THE CONTROLLER. ADDITIONALLY, MULTIPLE CONTROLLER POWER UP EVENTS WITHOUT MOTOR START EVENTS WERE LOGGED SINCE 23:07:44, LIKELY DUE TROUBLESHOOTING OF THE CONTROLLER. IT IS LIKELY THE VAD DISCONNECT ALARM CONTRIBUTED TO THE REPORTED "UNKNOWN ALARMS". AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON THE ONE ATTACHED POWER SOURCE. THE MOST LIKELY ROOT CAUSE OF THE BENT PIN WITHIN THE POWER PORT EVENT CAN BE ATTRIBUTED TO A MISALIGNMENT BETWEEN THE POWER PORT AND A POWER SOURCE OUTPUT CONNECTOR. CAPA PR00384004 WAS OPENED TO INVESTIGATE BENT/DAMAGED PINS WITH CONTROLLER 2.0. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARM EVENT CAN BE ATTRIBUTED TO THE INABILITY TO CONNECT A POWER SOURCE TO THE CONTROLLER. THE MOST LIKELY ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING OF THE CONTROLLER. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL PRODUCTS: H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C0706, C15, C19 H6: FDA CONCLUSION CODE(S): D11, D12, D15 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. 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 FURTHER REPORTED THAT THE CONTROLLER HAD UNEXPECTED LOSSES OF POWER AND THE VAD EXHIBITED A VAD STOPPED ALARM.
IT WAS FURTHER REPORTED THAT THE CONTROLLER HAD UNEXPECTED LOSSES OF POWER AND THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED A VAD STOPPED ALARM.
ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM CONTROLLER (B)(4), MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 30-NOV-2020 / SERIAL #: (B)(4) UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 05-NOV-2019, LABELED FOR SINGLE USE: NO, (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE RECALL NUMBER. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE CONTROLLER EXHIBITED POWER DISCONNECT AND UNKNOWN ALARMS. ALL VENTRICULAR ASSIST DEVICE (VAD) CONNECTIONS WERE CHECKED AND THE ALARM CONTINUED. THE CONTROLLER AC ADAPTER IN USE WAS EXCHANGED WITH A BATTERY AND THE ALARM CONTINUED. THE PATIENT WENT TO GET ANOTHER 'FRESH' BATTERY AND SUBSEQUENTLY DIED. THE CAUSE OF DEATH WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5855 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707003261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Death | ST. JUDE ICD |