HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 1.0
Report
- Report Number
- 3007042319-2018-02428
- Event Type
- Malfunction
- Date Received
- June 13, 2018
- Date of Event
- May 5, 2018
- Report Date
- August 19, 2019
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
CORRECTION: DATE REC¿D BY MFR. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
PRODUCT EVENT SUMMARY: ONE CONTROLLER, EIGHT BATTERIES, AND ONE CONTROLLER AC ADAPTER WERE NOT RETURNED FOR EVALUATION. LOG FILE AN ALYSIS 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 FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT201534, BAT201467, BAT201590, BAT205329, BAT205533, BAT201647, BAT201613, AND BAT201468 AND SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO COMMUNICATION ERRORS INVOLVING BATTERIES BAT205533, BAT205329, BAT201647, BAT201613, BAT201468, AND BAT201467. ANALYSIS OF THE EVENT FILES REVEALED FIVE CONTROLLER POWER UP EVENTS LOGGED WITHIN THE ANALYZED PERIOD, INDICATING LOSSES OF POWER TO THE CONTROLLER. THE CONTROLLER POWER UP EVENTS WERE LOGGED ON (B)(6) 2018 AT 22:44:56, 04/26/2018 AT 19:58:49, (B)(6) 2018 AT 18:07:38, (B)(6) 2018 AT 17:38:36, AND (B)(6) 2018 AT 19:50:02. THE MAXIMUM TIME THE CONTROLLER COULD HAVE BEEN WITHOUT POWER DURING THESE POWER LOSS EVENTS IS 13 MINUTES AD 40 SECONDS, 14 MINUTES AND 30 SECONDS, 28 SECONDS, 13 MINUTES AND 9 SECONDS, AND 2 MINUTES AND 21 SECONDS, RESPECTIVELY. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE PREMATURE POWER SWITCHING EVENTS WERE LIKELY PERCEIVED BY THE PATIENT AS BATTERY DISCONNECTIONS AND "IRREGULAR BATTERY CAPACITY CHANGES." 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 ONE OR BOTH POWER SOURCES. BATTERY BAT201613 D4: EXPIRATION DATE: 2015-07-31 UDI #: (B)(4). YES H4: MFG DATE: 2014-07-31. FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213. FDA CONCLUSION CODE(S): 12 BATTERY BAT201468 D4: EXPIRATION DATE: 2015-10-31 UDI #: 00888707001373 H3: YES H4: MFG DATE: 2014-10-31 H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY BAT201534 D4: EXPIRATION DATE: 2015-10-31 UDI #: (B)(4). H3: YES H4: MFG DATE: 2014-10-31 H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY BAT201467 D4: EXPIRATION DATE: 2015-10-31 UDI #: 00888707001373 H3: YES H4: MFG DATE: 2014-10-31 H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY BAT201590 D4: EXPIRATION DATE: 2015-10-31 UDI #: (B)(4). YES MFG DATE: 2014-10-31. FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY BAT201647 D4: EXPIRATION DATE: 2015-10-31 UDI #: (B)(4). H3: YES H4: MFG DATE: 2014-10-31 H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY BAT205329 D4: EXPIRATION DATE: 2016-02-29 UDI #: 00888707001373 H3: YES H4: MFG DATE: 2015-02-28 H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY BAT205533 D4: EXPIRATION DATE: 2016-03-31 UDI #: 00888707001373 H3: YES H4: MFG DATE: 2015-03-31 H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 CAC ADAPTOR UNKNOWN D4: EXPIRATION DATE: UNKNOWN UDI #: ASKU H3: YES H4: MFG DATE: UNKNOWN H6 FDA METHOD CODE(S): 4114, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
CORRECTIONS: B5, H6, H10 PRODUCT EVENT SUMMARY: ONE CONTROLLER, EIGHT BATTERIES (B)(4) AND ONE CONTROLLER AC ADAPTER WITH UNKNOWN SERIAL NUMBER WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT 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 RELATIVE STATE OF CHARGE (RSOC) BETWEEN 101-201 INVOLVING (B)(4) WHICH IS INDICATIVE OF A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. FURTHER ANALYSIS REVEALED MULTIPLE PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS INVOLVING (B)(4). ANALYSIS OF THE ALARM LOG FILE REVEALED SEVERAL CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). ANALYSIS OF THE EVENT FILES REVEALED FIVE (5) CONTROLLER POWER UP EVENTS LOGGED WITHIN THE ANALYZED PERIOD, INDICATING LOSSES OF POWER TO THE CONTROLLER. THE CONTROLLER POWER UP EVENTS WERE LOGGED ON (B)(6) 2018 AT 22:44:56, (B)(6) 2018 AT 19:58:49, (B)(6) 2018 AT 18:07:38, (B)(6) 2018 AT 17:38:36, AND (B)(6) 2018 AT 19:50:02. THE CONTROLLER WAS WITHOUT POWER FOR A MAXIMUM OF 13 MINUTES AND 40 SECONDS, 14 MINUTES AND 30 SECONDS, 28 SECONDS, 13 MINUTES AND 9 SECONDS, AND 2 MINUTES AND 21 SECONDS, RESPECTIVELY. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED IRREGULAR BATTERY CAPACITIES (RSOC BETWEEN 101-201) CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. POSSIBLE ROOT CAUSES OF THE COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERY, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS. THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. 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 ONE OR BOTH POWER SO URCES. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D4: CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-2015 / SERIAL #: (B)(4) H3: YES H4: MFG DATE: 31-OCT-2014 H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650DE / SERIAL #: (B)(4) H3: YES H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650DE / SERIAL #: (B)(4) H3: YES H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 67 D4: CATALOG #: 1650DE / SERIAL #: (B)(4) H3: YES H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650DE / SERIAL #: (B)(4) H3: YES H6: FDA RESULTS CODE(S): 213 H6: FDA CONCLUSION CODE(S): 67 D4: CATALOG #: 1650DE / SERIAL #: (B)(4). H3: YES H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650DE / SERIAL #: (B)(4) H3: YES H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650DE / SERIAL #: (B)(4). H3: YES H6: FDA CONCLUSION CODE(S): 4307 THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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.
INITIAL MDR DATE MFR REC: 2018-05-19 . THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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.
LOG FILE REVIEW INDICATED THAT SIX OF THE BATTERIES ALSO HAD A COMMUNICATION ERROR. ONE OF THE BATTERIES ALSO EXHIBITED A CRITICAL B BATTERY ALARM.
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2015-07-31 UDI #: (B)(4). MFG DATE: 2014-07-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31. UDI #: (B)(4). MFG DATE: 2014-10-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31. UDI #: (B)(4). MFG DATE: 2014-10-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4). MFG DATE: 2014-10-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31. UDI #: (B)(4). MFG DATE: 2014-10-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31. UDI #: (B)(4). MFG DATE: 2014-10-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2016-02-29. UDI #: (B)(4). MFG DATE: 2015-02-28. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) /MODEL #: 1650DE / EXPIRATION DATE: 2016-03-31. UDI #: (B)(4). MFG DATE: 2015-03-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTOR. CAC ADAPTOR / UNKNOWN /MODEL #: 1640DE / EXPIRATION DATE: UNKNOWN. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) CONTROLLER EXHIBITED POWER UPS AND POWER SWITCHING. ASSOCIATED BATTERIES EXHIBITED POWER SWITCHING, DISCONNECTIONS, AND IRREGULAR BATTERY CAPACITY CHANGES. THE AC ADAPTOR EXHIBITED POWER SWITCHING. THE CONTROLLER, BATTERIES, AND AC ADAPTOR WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440410 | HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER 1.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1407DE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1104 VAD |