HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER
Report
- Report Number
- 3007042319-2020-06039
- Event Type
- Malfunction
- Date Received
- October 9, 2020
- Date of Event
- July 23, 2020
- Report Date
- April 7, 2021
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
CORRECTION: B5 A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR A CORRECTION. B5 DESCRIPTION OF EVENT PROBLEM CORRECTED TO CLARIFY THAT THERE WAS NOT A LOSS OF POWER TO THE CONTROLLER ASSOCIATED WITH THE CONTROLLER AC ADAPTERS AND BATTERIES. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16 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.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION AND FOR AN UPDATE TO THE PRODUCT EVENT SUMMARY. PRODUCT EVENT SUMMARY: ONE CONTROLLER, TWO CONTROLLER AC ADAPTERS, AND EIGHT BATTERIES WITH UNKNOWN SERIAL NUMBERS WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS WAS NOT CONDUCTED SINCE LOG FILES WERE NOT AVAILABLE. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED. A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND POWER SOURCES. HOWEVER, THE REPORTED BEEPS ARE MOST LIKELY ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND POWER SOURCES. 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 DEVICE INVESTIGATION. PRODUCT EVENT SUMMARY: ONE CONTROLLER, TWO CONTROLLER AC ADAPTERS, AND EIGHT BATTERIES WITH UNKNOWN SERIAL NUMBERS WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS WAS NOT CONDUCTED SINCE LOG FILES WERE NOT AVAILABLE. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED. A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND POWER SOURCES. HOWEVER, THE REPORTED BEEPS ARE MOST LIKELY ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND POWER SOURCES. A POSSIBLE ROOT CAUSE OF THE REPORTED LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. 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.
IT WAS ALSO REPORTED THAT THERE WAS NOT A LOSS OF POWER TO THE CONTROLLER ASSOCIATED WITH THE CONTROLLER AC ADAPTERS AND BATTERIES.
THIS INITIAL REPORT IS BASED SOLELY ON THE RECEIPT OF A MAUDE REPORT. MAUDE DATABASE REPORT NUMBER: MW5096099. DATE OF THIS REPORT: 13-AUG-2020. REPORT SENT TO FDA: YES, 17-AUG-2020. REPORT SENT TO MANUFACTURER: UNKNOWN. (B)(4). ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. CONCOMITANT MEDICAL PRODUCTS: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, SERIAL #: UNK, UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE MANUFACTURE DATE: UNK. 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.
IT WAS REPORTED THAT THE CONTROLLER EXHIBITED BEEPING, POWER SWITCHING AND A LOSS OF POWER ASSOCIATED WITH THE CONTROLLER AC ADAPTERS AND BATTERIES. THE CONTROLLER REMAINS IN USE, AND THE CONTROLLER AC ADAPTER AND 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 |
|---|---|---|---|---|---|---|---|
| 1121383 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MCS UNKNOWN VAD. |