HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2020-05248
- Event Type
- Malfunction
- Date Received
- August 6, 2020
- Date of Event
- July 9, 2020
- Report Date
- July 11, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707006859
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1903-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR AN UPDATE TO: -B5.DESC EVT PROBLEM & H10. ADDITIONAL PRODUCTS: IMG (ANNEX G) COMPONENT CODE ADDITIONAL PRODUCTS: D4: (B)(6), H6: IMG CODE(S): G02002 D4: (B)(6), H6: IMG CODE(S): G02002 D4: (B)(6), H6: IMG CODE(S): G02002 D4: (B)(6),H6: IMG CODE(S): G02002 D4: (B)(6), H6: IMG CODE(S): G02002 D4: (B)(6), H6: IMG CODE(S): G02002 D4: (B)(6), H6: IMG CODE(S): G02002 D4: (B)(6), H6: IMG CODE(S): G02002 D4: CAC215557 D4: CAC300012 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 AN UPDATE TO H10. PRODUCT EVENT SUMMARY AND CODING CORRECTION FOR THE CONTROLLER AND TWO CAC ADAPTERS. PRODUCT EVENT SUMMARY: THE CONTROLLER (B)(6), EIGHT (8) BATTERIES (B)(6), AND TWO (2) CONTROLLER AC ADAPTERS (B)(6) WERE 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 AND CONTROLLER AC ADAPTERS REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED CONTAMINATION WITHIN BOTH POWER PORTS OF THE CONTROLLER, LIKELY DUE TO THE HANDLING OF THE DEVICE. SUPPLEMENTAL TESTING WAS PERFORMED ON THE CONTROLLER AND THE TEST RESULTS REVEALED THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. 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 FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6), AND A POWER ADAPTER. ADDITIONALLY, REVIEW OF EVENT LOG FILES REVEALED THREE (3) CONTROLLER POWER UP EVENTS ON 10/MAY/2020 AT 17:58:40, ON 21/MAY/2020 AT 08:21:40, AND ON 24/MAY/2020 AT 05:38:48. THE CONTROLLER CAN ONLY STORE A MAXIMUM OF 30 DAYS OF DATA. AFTER REACHING THE LIMIT, THE CONTROLLER INITIATES A FIRST-IN FIRST-OUT METHOD WHEREBY THE OLDEST DATA POINT IS DELETED TO ALLOW THE NEWEST DATA POINT TO BE RECORDED. THUS, DATA LOGS PRIOR TO AND FOLLOWING THE POWER UP EVENTS WERE NOT AVAILABLE. THE CONTROLLER WAS WITHOUT POWER FOR 13 SECONDS, 13 SECONDS, AND 14 SECONDS, RESPECTIVELY. ANALYSIS OF THE ALARM LOG FILE DID NOT REVEAL ANY CRITICAL BATTERY ALARMS LOGGED WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED POWER SWITCHING AND LOSS OF POWER EVENTS WERE CONFIRMED; HOWEVER THE REPORTED CRITICAL POWER ALARM EVENT COULD NOT BE CONFIRMED. (B)(6) WERE LUBRICATED PRIOR TO THE RELEASE. THERE IS NO EVIDENCE OF A POWER SOURCE LUBRICATION PROCEDURE PERFORMED ON (B)(6). THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO CONTAMINATION WITHIN THE POWER PORTS AND/OR DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS PRIOR TO LUBRICATION SERVICING. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) FALL WITHIN THE BOUNDS OF THIS CAPA. 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. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. ADDITIONAL PRODUCTS: D4: (B)(6). H6: IMG CODE(S): G04035. D4: (B)(6). H6: IMG CODE(S): G04035. 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 SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE CONTROLLER, EIGHT (8) BATTERIES AND TWO (2) CONTROLLER AC ADAPTERS WERE 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 AND CONTROLLER AC ADAPTERS REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED CONTAMINATION WITHIN BOTH POWER PORTS OF THE CONTROLLER, LIKELY DUE TO THE HANDLING OF THE DEVICE. SUPPLEMENTAL TESTING WAS PERFORMED ON THE CONTROLLER AND THE TEST RESULTS REVEALED THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. 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 FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(6), AND A POWER ADAPTER. ADDITIONALLY, REVIEW OF EVENT LOG FILES REVEALED THREE (3) CONTROLLER POWER UP EVENTS ON (B)(6)2020 AT 17:58:40, 08:21:40, AND 05:38:48. THE CONTROLLER CAN ONLY STORE A MAXIMUM OF 30 DAYS OF DATA. AFTER REACHING THE LIMIT, THE CONTROLLER INITIATES A FIRST-IN FIRST-OUT METHOD WHEREBY THE OLDEST DATA POINT IS DELETED TO ALLOW THE NEWEST DATA POINT TO BE RECORDED. THUS, DATA LOGS PRIOR TO AND FOLLOWING THE POWER UP EVENTS WERE NOT AVAILABLE. THE CONTROLLER WAS WITHOUT POWER FOR 13 SECONDS, 13 SECONDS, AND 14 SECONDS, RESPECTIVELY. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. (B)(6) WERE LUBRICATED PRIOR TO THE RELEASE. THERE IS NO EVIDENCE OF A POWER SOURCE LUBRICATION PROCEDURE PERFORMED ON (B)(6). THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO CONTAMINATION WITHIN THE POWER PORTS AND/OR DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS PRIOR TO LUBRICATION SERVICING. 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. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 4307. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 4307. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 4307. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 213 H6: CONCLUSION CODE(S): 67. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 213 H6: CONCLUSION CODE(S): 67. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 4307. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 213 H6: CONCLUSION CODE(S): 67. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 4307. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 12. D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ AC ADAPTER D4: SERIAL #: (B)(6) D10: YES, 11-AUG-2020 H3: YES H6: METHOD CODE(S): 10, 4112 H6: RESULTS CODE(S): 3213 H6: CONCLUSION CODE(S): 4307. 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 FURTHER REPORTED THAT THE PATIENT STATED BEFORE BED, WOULD PLUG INTO AC POWER AND A BATTERY THAT DOES NOT HAVE A FULL CHARGE AND WAS AWAKENED WITH ALARMS AND THE BATTERY WAS AT CRITICAL POWER. THE PATIENT STATED THAT THIS HAS BEEN HAPPENING FOR SEVERAL MONTHS.
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. CONCOMITANT MEDICAL PRODUCTS: DTMB1QQ BI-V ICD IMPLANTED (B)(6) 2016. 429888 LEAD IMPLANTED (B)(6) 2016. 5076-52 LEAD IMPLANTED (B)(6) 2016. 6935M62 LEAD IMPLANTED (B)(6) 2016. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY , MEDICAL DEVICE: MODEL #: 1650DE/ CATALOG #: 1650DE / EXPIRATION DATE: 09-SEP-2020, SERIAL #: (B)(4), UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MANUFACTURER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: 20-SEP-2019. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MEDICAL DEVICE: MODEL #: 1650DE/ CATALOG #: 1650DE / EXPIRATION DATE: 09-SEP-2020 SERIAL #: (B)(4), UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MANUFACTURER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: 20-SEP-2019. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MEDICAL DEVICE: MODEL #: 1650DE/ CATALOG #: 1650DE / EXPIRATION DATE: 09-SEP-2020, SERIAL #: (B)(4), UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MANUFACTURER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: 20-SEP-2019. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY , MEDICAL DEVICE: MODEL #: 1650DE/ CATALOG #: 1650DE / EXPIRATION DATE: 09-SEP-2020, SERIAL #: (B)(4), UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MANUFACTURER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: 20-SEP-2019. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MEDICAL DEVICE: MODEL #: 1650DE/ CATALOG #: 1650DE / EXPIRATION DATE: 09-SEP-2020, SERIAL #: (B)(4), UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MANUFACTURER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: 24-SEP-2019. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MEDICAL DEVICE: MODEL #: 1650DE/ CATALOG #: 1650DE / EXPIRATION DATE: 09-SEP-2020, SERIAL #: (B)(4), UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: 21-SEP-2019. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MEDICAL DEVICE: MODEL #: 1650DE/ CATALOG #: 1650DE / EXPIRATION DATE: 09-SEP-2020 SERIAL #: (B)(4), UDI (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. LABELED FOR SINGLE USE? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: 21-SEP-2019. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM AC ADAPTER, MEDICAL DEVICE: MODEL #: 1430US/ CATALOG #: 1430US / EXPIRATION DATE: UNK, SERIAL #: (B)(4), UDI (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MANUFACTUER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG DATE: UNK. LABELED FOR SINGLE USE? NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM AC ADAPTER, MEDICAL DEVICE: MODEL #: 1430US/ CATALOG #: 1430US / EXPIRATION DATE: UNK SERIAL #: (B)(4), UDI: (B)(4). DEVICE AVAILABLE FOR EVALUATION? NO DEVICE EVALUATED BY MANUFACTUER? NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. DEVICE MFG 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. 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 WAS USING TWO SOURCES OF POWER AT ONCE AND THAT THE BATTERIES WERE DRAINING WHILE CONNECTED TO AC POWER DESPITE THE CONTROLLER DISPLAYING THAT IT WAS CONNECTED TO AC POWER; THIS OCCURS ON BOTH POWER PORTS OF THE CONTROLLER. ADDITIONALLY, THE BATTERIES ARE DRAINING POWER AT THE SAME TIME WHEN THE CONTROLLER IS USING TWO BATTERIES. POWER SWITCHING WAS SUSPECTED AND ALSO RESULTED IN PUMP STOPS. THE AC POWER CORD AND BATTERIES WERE REPLACED. DESPITE CHANGING BATTERIES, THE POWER SWITCHING PERSISTED AND THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 839246 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707006859 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | 1103 VAD |