HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-03469
- Event Type
- Malfunction
- Date Received
- August 6, 2018
- Date of Event
- July 5, 2018
- Report Date
- August 12, 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
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: SIX BATTERIES WERE RETURNED FOR ANALYSIS. THE CONTROLLER WAS NOT RETURNED FOR EVALUATION. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS 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 (B)(4), AS WELL AS SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILES REVEALED ONE CRITICAL BATTERY ALARM LOGGED ON (B)(4) ON (B)(6) 2018 AT 21:46:47 DUE TO A COMMUNICATION ERROR. ANALYSIS OF THE EVENT LOG FILE REVEALED ONE CONTROLLER POWER UP EVENT ON (B)(6) 2018, INDICATING A LOSS OF POWER TO THE CONTROLLER. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE WITH 24% RELATIVE STATE OF CHARGE (RSOC) AND (B)(4) WAS CONNECTED TO POWER PORT TWO; (B)(4) HAD EXPERIENCED A MOMENTARY DISCONNECTION WITHIN THE PRECEDING 15 MINUTES. THE DATA POINT AFTER THE CONTROLLER POWER UP EVENT REVEALED THAT THE (B)(4) WAS CONNECTED TO POWER PORT ONE AND (B)(4) WAS CONNECTED TO POWER PORT TWO. THE CONTROLLER WAS WITHOUT POWER FOR 10 SECONDS. AS A RESULT, THE REPORTED POWER SWITCHING, CRITICAL BATTERY ALARM, AND LOSS OF POWER EVENTS WERE CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. BASED ON THE LOG FILE ANALYSIS, THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DIS CONNECTIONS AND COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. A POSSIBLE ROOT CAUSE OF THE 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. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE EVENTS INVOLVING THE CONTROLLER LOSING POWER AND MOMENTARY DISCONNECTIONS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. ADDITIONAL PRODUCTS: (B)(4). 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: SIX (6) BATTERIES WERE RETURNED FOR ANALYSIS. ONE (1) CONTROLLER WAS NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(6), 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 (B)(6), AS WELL AS SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(6). ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILES REVEALED ONE CRITICAL BATTERY ALARM LOGGED ON (B)(6) ON (B)(6) 2018 AT 21:46:47 DUE TO A COMMUNICATION ERROR. ANALYSIS OF THE EVENT LOG FILE REVEALED ONE CONTROLLER POWER UP EVENT ON (B)(6) 2018 AT 13:46:25. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 24% RELATIVE STATE OF CHARGE (RSOC) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2); (B)(6) HAD EXPERIENCED A MOMENTARY DISCONNECTION WITHIN THE PRECEDING 15 MINUTES. THE DATA POINT AFTER THE CONTROLLER POWER UP EVENT REVEALED THAT THE (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR 10 SECONDS. AS A RESULT, THE REPORTED POWER SWITCHING, CRITICAL BATTERY ALARM, AND LOSS OF POWER EVENTS WERE CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. BASED ON THE LOG FILE ANALYSIS, THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. A POSSIBLE ROOT CAUSE OF THE 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. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. AN INTERNAL INVESTIGATION WAS INITIATED TO INVESTIGATE MOMENTARY DISCONNECTIONS. 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.
PRODUCT EVENT SUMMARY: SIX BATTERIES ((B)(6)) WERE RETURNED FOR ANALYSIS. ONE CONTROLLER WAS NOT RETURNED FOR EVALUATION. 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 EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS 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 (B)(6), AS WELL AS SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO COMMUNICATION ERRORS INVOLVING (B)(6). FURTHERMORE, THE DATA LOG FILES REVEALED A RELATIVE STATE OF CHARGE (RSOC) BETWEEN 101-201 INVOLVING (B)(6), WHICH IS INDICATIVE OF COMMUNICATION ERRORS. ADDITIONALLY, ANALYSIS OF THE ALARM LOG FILES REVEALED ONE CRITICAL BATTERY ALARM LOGGED ON (B)(6) ON (B)(6) 2018 AT 21:46:47 DUE TO A COMMUNICATION ERROR. ANALYSIS OF THE EVENT LOG FILE REVEALED ONE CONTROLLER POWER UP EVENT ON (B)(6) 2018 AT 13:46:25. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(6) WAS CON NECTED TO POWER PORT ONE (1) WITH 24% RELATIVE STATE OF CHARGE (RSOC) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2); (B)(6) HAD EXPERIENCED A MOMENTARY DISCONNECTION WITHIN THE PRECEDING 15 MINUTES. THE DATA POINT AFTER THE CONTROLLER POWER UP EVENT REVEALED THAT THE (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR 10 SECONDS. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE REPORTED DEVICES. BASED ON THE LOG FILE ANALYSIS, THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. POSSIBLE ROOT CAUSES OF THE REPORTED COMMUNICATION ERROR 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. A POSSIBLE ROOT CAUSE OF THE 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. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 23-JUL-2018 H3: YES DEV RTN TO MFR? YES H6: PATIENT CODE(S): C76143 H6: FDA CONCLUSION CODE(S): 4307 D4: SERIAL #: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 23-JUL-2018 H3: YES DEV RTN TO MFR? YES H6: PATIENT CODE(S): C76143 D4: SERIAL #: (B)(6) UDI #: (B)(4) H3: YES DEV RTN TO MFR? YES H6: PATIENT CODE(S): C76143 H6: FDA CONCLUSION CODE(S): 4307 D4: SERIAL #: (B)(6) UDI #: (B)(4) H3: YES DEV RTN TO MFR? YES H6: PATIENT CODE(S): C76143 D4: SERIAL #: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 23-JUL-2018 H3: YES DEV RTN TO MFR? YES H6: PATIENT CODE(S): C76143 D4: SERIAL #: (B)(6) UDI #: (B)(4) D10: YES, RETURN DATE: 23-JUL-2018 H3: YES DEV RTN TO MFR? YES H6: PATIENT CODE(S): C76143. 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 FIVE OF THE BATTERIES ALSO HAD A COMMUNICATION ERROR.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 / (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2019-03-31 RETURN DATE: 2018-07-23 MFG DATE: 2018-03-12 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2019-03-31 RETURN DATE: 2018-07-23 MFG DATE: 2018-03-08 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY / (B)(4) / MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2018-05-31 RETURN DATE: 2018-07-23 MFG DATE: 2017-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY/ (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2019-03-31 RETURN DATE: 2018-07-23 MFG DATE: 2018-03-05 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY/ (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2019-09-30 RETURN DATE: 2018-07-23 MFG DATE: 2018-09-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY/ (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 2018-05-31 RETURN DATE: 2018-07-23 MFG DATE: 2017-05-31 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED POWER SWITCHING ASSOCIATED WITH A LOSS OF POWER. THE POWER SWITCHING OCCURRED WHILE THE BATTERIES WERE AT OR GREATER THAN 25% CAPACITY. IN ADDITION, ONE OF THE BATTERIES WAS ALSO ASSOCIATED WITH A CRITICAL BATTERY ALARM. THE BATTERIES WILL BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595212 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | 1104-VAD| 1104-VAD |