HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-00907
- Event Type
- Death
- Date Received
- February 3, 2022
- Date of Event
- January 10, 2022
- Report Date
- October 24, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707002639
- PMA / PMN Number
- P100047
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER 2.0, MODEL #: 1420/ CATALOG #: 1420/ EXPIRATION DATE: 31-AUG-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 31-AUG-2017, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, MODEL #: 1650/ CATALOG #: 1650/ EXPIRATION DATE: 31-AUG-2019 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: 04-AUG-2018, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, MODEL #: 1650/ CATALOG #: 1650/ EXPIRATION DATE: 31-AUG-2019 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: 06-AUG-2018, 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 AN UPDATE TO: B5. DESC EVT PROBLEM, H6. PATIENT CODES (IME/ANNEX E) ADDITIONAL, PRODUCTS: D4: (B)(6), H6: PATIENT IME CODE(S): E0606, E0611, D4: (B)(6), H6: PATIENT IME CODE(S): E0606, E0611, D4: (B)(6), H6: PATIENT IME CODE(S): E0606, E0611. 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 SUMMARY. ADDITIONAL PRODUCTS: SERIAL# (B)(6) H3: YES H6:FDA METHOD CODE(S): B01, B15 H6:FDA RESULT CODE(S): C02, C07 H6:FDA CONCLUSION CODE(S): D02, D01, D15 H6: PATIENT IMG CODE(S): G0200701, G04070 SERIAL# (B)(6) H3: YES H6:FDA METHOD CODE(S): B15, B17 H6:FDA RESULT CODE(S): C19 H6:FDA CONCLUSION CODE(S): D14 SERIAL# (B)(6) H3: YES H6:FDA METHOD CODE(S): B15, B17 H6:FDA RESULT CODE(S): C19 H6:FDA CONCLUSION CODE(S): D14 PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) (B)(6) AND TWO (2) BATTERIES (B)(6) WERE NOT RETURNED FOR EVALUATION. THE CONTROLLER (B)(6) 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 THAT THE DEVICE PASSED FUNCTIONAL TESTING. A VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND BOTH POWER PORTS. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00381374, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) FALLS WITHIN THE BOUNDS OF THIS CAPA. REVIEW OF THE CONTROLLER LOG FILES REVEALED A SLIGHT INCREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS STARTING ON (B)(6) 2021, FOLLOWED BY A SHARP INCREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS BEGINNING ON (B)(6) 2022 TO PARAMETERS ABOVE THE NORMAL OPERATING RANGE. REVIEW OF THE CONTROLLER'S INTERNAL LOGS REVEALED SPIKES IN POWER CONSUMPTION ABOVE 37 WATTS BEGINNING ON (B)(6) 2022 SINCE 23:03:65. REVIEW OF THE ALARM LOG FILE REVEALED TWENTY-FIVE (25) HIGH WATT ALARMS WERE LOGGED SINCE (B)(6) 2022. ANALYSIS OF THE ALARM LOG FILE THEN REVEALED SIX (6) VAD DISCONNECT ALARMS LOGGED ON (B)(6) 2022 BETWEEN 23:04:58 AND 23:05:53. THE VAD DISCONNECT ALARMS WERE MOST LIKELY FALSE ALARMS, GIVEN THAT THE SPEED RECORDED AT THE ONSET OF THE ALARM WAS HIGHER THAN THE SET SPEED. THIS INDICATES THAT A POSSIBLE LOSS OF COMMUTATION OCCURRED. COMMUTATION IS THE PROCESS OF SWITCHING WINDING CURRENT TO GENERATE MOTION. IF THE PUMP ROTATIONAL SPEED DRIFTS HIGHER THAN THE SPEED SET-POINT, THE MOTOR VOLTAGE WILL DECREASE TO ACHIEVE THE DESIRED SPEED. HOWEVER, IF THERE IS NO CHANGE TO THE SPEED (SPEED READING REMAINS FROZEN), THE VOLTAGE WILL CONTINUE TO DECREASE TO ZERO. THIS LIKELY CAU SED THE CURRENT TO DECREASE TO ZERO, TRIGGERING A VAD DISCONNECT ALARM, EVEN IF THE DRIVELINE WAS STILL PHYSICALLY CONNECTED TO THE CONTROLLER. OF NOTE, THE VAD DISCONNECT ALARM LOGGED ON (B)(6) 2022 23:05:41 WAS MOST LIKELY A FALSE ALARM, GIVEN THAT THE VAD DISCONNECT ALARM CLEARED WITHIN TWO (2) SECONDS. EVEN THOUGH THE SPEED RECORDED AT THE ONSET OF THE VAD DISCONNECT ALARM WAS CLOSE TO THE SET SPEED, IT WAS LIKELY THAT THE SPEED DECREASED FROM A SPEED HIGHER THAN THE SET SPEED IN A SHORT PERIOD OF TIME BETWEEN THE DETECTION OF THE ALARM AND THE LOGGING OF THE PUMP PARAMETERS WHILE THE PUMP WAS BEING RESTARTED. ANALYSIS OF THE EVENT LOG FILE REVEALED TWO (2) CONTROLLER POWER UP EVENTS WITH ASSOCIATED PUMP START EVENTS LOGGED ON (B)(6) 2022 AT 23:40:03 AND (B)(6) 2022 AT 01:27:05. THE DATA POINT LOGGED IN THE CONTROLLER'S INTERNAL LOGS PRIOR TO THE FIRST LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 60% RELATIVE STATE OF CHARGE (RSOC) AND NO POWER SOURCE WAS CONNECTED TO POWER PORT TWO (2). THE DATA POINT RECORDED AFTER THE FIRST LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2). THE DATA POINT LOGGED IN THE CONTROLLER'S INTERNAL LOGS PRIOR TO THE SECOND LOSS OF POWER REVEALED NO POWER SOURCE WAS CONNECTED TO POWER PORT ONE (1) AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 42% RSOC. THE DATA POINT RECORDED AFTER THE SECOND LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) AND NO POWER SOURCE WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR 9 SECONDS AND 1 MINUTE AND 43 SECONDS, RESPECTIVELY. IN ADDITION, REVIEW OF THE ALARM LOG FILE REVEALED FIFTY-THREE (53) POWER DISCONNECT ALARMS LOGGED BETWEEN (B)(6)2022 AT 23:07:21 AND (B)(6) 2022 AT 00:31:35 INVOLVING (B)(6) AND (B)(6). DURING THE POWER DISCONNECT ALARMS, REVIEW OF THE DATA LOG FILE REVEALED SAFETY ALERT WORD (SAW) VALUES WERE RECORDED ON (B)(6) AND (B)(6), INDICATING OVERCURRENT ALERTS. PUMP'S POWER CONSUMPTION WAS SIGNIFICANTLY ABOVE NORMAL OPERATING RANGE DURING THE POWER DISCONNECT ALARMS. REVIEW OF THE CONTROLLER'S INTERNAL LOGS ALSO REVEALED A SAW VALUE INVOLVING (B)(6), INDICATING A CELL UNDER VOLTAGE AND A SAW VALUE INVOLVING (B)(6) INDICATING AN OVER TEMPERATURE ALERT LOGGED ON (B)(6) 2022 BETWEEN 01:25:16 AND 01:25:18. IT IS LIKELY THE OVERCURRENT CONDITION, CELL UNDER VOLTAGE CONDITION, OVER TEMPERATURE CONDITION PREVENTED THE BATTERIES FROM PROVIDING POWER, RESULTING IN THE POWER DISCONNECT ALARMS AND LOSSES OF POWER TO THE CONTROLLER. REVIEW OF THE ALARM LOG FILE REVEALED FORTY-TWO (42) CONTROLLER FAULT ALARMS LOGGED ON (B)(6) 2022 BETWEEN 00:35:05 AND 00:59:47, INDICATING A POWER OUT OF RANGE CONDITION INVOLVING (B)(6). PRIOR TO THE FIRST CONTROLLER FAULT ALARM, (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 35% RSOC AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 95% RSOC. THE CONTROLLER FAULT ALARMS WERE DUE TO THE BATTERIES RAPIDLY DEPLETING BELOW 0% RSOC. PER THE INSTRUCTIONS FOR USE (IFU), THE CAPACITY OF A BATTERY IS DEPENDENT ON THE CONTROLLER AND PUMP OPERATING POWER CONSUMPTION. CONSIDERING THAT THE PUMP'S POWER CONSUMPTION WAS SIGNIFICANTLY ABOVE NORMAL OPERATING RANGE ON THE REPORTED EVENT, IT IS EXPECTED THAT THE BATTERIES WOULD BE ABLE TO PROVIDE POWER TO THE CONTROLLER FOR A SHORTER PERIOD OF TIME. A CRITICAL BATTERY ALARM WAS LOGGED ON (B)(6) 2022 01:25:22 INVOLVING (B)(6) DUE TO BATTERY BELOW 10% RSOC BEING CONNECTED TO THE CONTROLLER AFTER THE SECOND LOSS OF POWER. THIS WAS FOLLOWED BY A VAD DISCONNECT ALARM LOGGED ON (B)(6) 2022 AT 01:27:46 INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER, LIKELY DUE TO TROUBLESHOOTING. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT MAY BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. POSSIBLE CAUSES OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED TO A LOSS OF SYNCHRONIZATION OF COMMUTATION, LEADING TO FALSE VAD DISCONNECT ALARMS, AND/OR A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. CAPA PR00550440 IS INVESTIGATING CONTROLLER LOSSES OF SYNCHRONIZATION OF COMMUTATION. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CRITICAL BATTERY ALARM CAN BE ATTRIBUTED TO A BATTERY DEPLETING BELOW 10% RSOC. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARMS, CONTROLLER FAULT ALARMS, AND OBSERVED SAW VALUES CAN BE ATTRIBUTED TO, BUT NOT LIMITED TO THE INCREASED POWER CONSUMPTION REQUIRED BY THE PUMP RUNNING AT HIGH POWER, DRAWING MORE CURRENT FROM THE BATTERIES. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO THE DISCONNECTION OF A SINGLE POWER SOURCE FROM THE CONTROLLER AND/OR TO THE INCREASED POWER CONSUMPTION REQUIRED BY THE PUMP RUNNING AT HIGH POWER DRAWING MORE CURRENT FROM THE BATTERY, PREVENTING THE BATTERY FROM PROVIDING POWER TO THE CONTROLLER. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. INFORMATION RECEIVED FROM THE SITE INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. THE CAUSE OF DEATH WAS DEEMED TO BE PUMP THROMBOSIS, NON-ISCHEMIC CARDIOMYOPATHY (NICM) AND CONGESTIVE HEART FAILURE (CHF). BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, DEVICE THROMBUS AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE IMPLANTATION OF A VAD. BASED ON REVIEW OF PAST ADVERSE EVENTS FOR THIS PATIENT, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF THROMBUS. BASED ON REVIEW OF PAST ADVERSE EVENTS FOR THIS PATIENT, IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF THROMBUS EVENTS. 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. B2: UPDATED TO REFLECT PATIENT DEATH. B7: UPDATED TO INCLUDED NON-ISCHEMIC CARDIOMYOPATHY. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6); D9: YES, RETURN DATE: 16-MAR-2022; H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES; H6: IMF CODE(S): F02 D4: SERIAL OR LOT#: (B)(6); H6: IMF CODE(S): F02; D4: SERIAL OR LOT#:(B)(6); H6: IMF CODE(S): F02 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.
IT WAS REPORTED THAT REVIEW OF LOG FILES REVEALED LOSS OF POWER TO THE CONTROLLER, MULTIPLE HIGH WATTS AND VENTRICULAR ASSIST DEVICE (VAD) DISCONNECT ALARMS, AND CONTROLLER FAULT ALARMS. IN ADDITION, THE BATTERIES EXHIBITED POWER DISCONNECTS ALARMS. IT WAS REPORTED THAT THE CONTROLLER MALFUNCTIONED AND DID NOT RECOGNIZE THE BATTERIES CONNECTED TO IT RESULTING IN TWO VAD STOPS, WHICH CONTRIBUTED TO THE SUSPECTED VAD THROMBOSIS THAT THE PATIENT SUFFERED. IT WAS NOTED THAT THE DRIVELINE WAS NEVER DISCONNECTED FROM THE CONTROLLER. THE VAD AND BATTERIES REMAINS IN USE AND THE CONTROLLER WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS ALSO FURTHER REPORTED THAT THE CAUSE OF DEATH WAS DEEMED TO BE PUMP THROMBOSIS, NON-ISCHEMIC CARDIOMYOPATHY (NICM) AND CONGESTIVE HEART FAILURE (CHF).
IT WAS FURTHER REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1748644 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707002639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Death| L |