HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

Report

Report Number: 3007042319-2021-05593
Event Type: Death
Date Received: August 5, 2021
Date of Event: July 26, 2021
Report Date: November 12, 2021
Manufacturer: HEARTWARE, INC.
Product Code: DSQ
UDI-DI: 00888707000017
PMA / PMN Number: P100047
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE ANALYSIS AND INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) (B)(6) AND TWO (2) BATTERIES WITH UNKNOWN SERIAL NUMBERS WERE NOT RETURNED FOR EVALUATION. TWO (2) CONTROLLERS (B)(6) WERE RETURNED FOR EVALUATION. NO PERFORMANCE ALLEGATIONS WERE MADE AGAINST (B)(6). VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF (B)(6) REVEALED THAT THE CONTROLLER PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF (B)(6) REVEALED CONTAMINATION WITH BOTH POWER PORTS AND THE PUMP CONNECTOR OF THE CONTROLLER. VISUAL INSPECTION OF (B)(6) REVEALED CONTAMINATION WITH BOTH POWER PORTS, THE SERIAL PORT, AND THE PUMP CONNECTOR OF THE CONTROLLER. ADDITIONALLY, VISUAL INSPECTION OF (B)(6) REVEALED SCRATCHES ON THE CONTROLLER'S LIQUID CRYSTAL DISPLAY (LCD) ON THE FRONT PANEL WINDOW; HOWEVER, THE OBSERVED SCRATCHES DID NOT INTERFERE WITH THE FUNCTIONALITY OF THE DISPLAY. FUNCTIONAL TESTING OF (B)(6) REVEALED THAT THE NO POWER ALARM ONLY SOUNDED BRIEFLY WHEN BOTH POWER SOURCES WERE DISCONNECTED FROM THE CONTROLLER AND THE CONTROLLER EXHIBITED A CONTROLLER FAULT ALARM DURING BENCH TESTING, WHICH INDICATED AN ISSUE WITH THE INTERNAL BATTERY. INTERNAL INSPECTION REVEALED THAT THE INTERNAL NICKEL-METAL HYDRIDE (NIMH) BATTERY, WHICH POWERS THE NO POWER ALARM, WAS SWOLLEN. AFTER THE INTERNAL BATTERY WAS REPLACED, THE CONTROLLER PERFORMED AS INTENDED. IN ADDITION, LOG FILE ANALYSIS REVEALED THAT (B)(6) HAD BEEN IN USE FOR MORE THAN TWO (2) YEARS. THE OBSERVED CONTROLLER CONNECTOR CONTAMINATION, LCD SCRATCHES, AND BRIEF SOUNDING OF THE NO POWER ALARM/CONTROLLER FAULT ALARM ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CONTAMINATION WITH THE CONTROLLERS' PORTS AND THE OBSERVED SCRATCHES ON THE CONTROLLER DISPLAY CAN BE ATTRIBUTED TO HANDLING OF THE DEVICES. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED BRIEF SOUNDING OF THE NO POWER ALARM AND CONTROLLER FAULT ALARM DURING BENCH TESTING CAN BE ATTRIBUTED TO A REDUCED CHARGE CAPACITY OF THE INTERNAL NIMH BATTERY. CAPA PR00492825 WAS OPENED TO INVESTIGATE INTERNAL BATTERY ISSUES WITH CONTROLLER 2.0. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS NOT IN USE DURING THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED THAT (B)(6) WAS THE PATIEN T'S PRIMARY CONTROLLER. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH (B)(6) REVEALED TWO (2) CONTROLLER POWER-UP EVENTS LOGGED ON 26-JUL-2021 AT 11:38:47 AND 11:39:00, WITH AN ASSOCIATED MOTOR START EVENT AT 11:39:03. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT 1 WITH 53% RELATIVE STATE OF CHARGE (RSOC) AND A POWER ADAPTER WAS CONNECTED TO POWER PORT 2. REVIEW OF THE CONTROLLER'S INTERNAL LOGS REVEALED THAT THE POWER ADAPTER WAS DISCONNECTED FROM THE CONTROLLER AT 05:41:52, PRIOR TO THE LOSS OF POWER. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT 1 AND NO POWER SOURCE WAS CONNECTED TO POWER PORT 2. THE CONTROLLER WAS WITHOUT POWER FOR A MAXIMUM OF 5 HOURS, 55 MINUTES, AND 16 SECONDS. NO ANOMALIES WERE OBSERVED LEADING UP TO THE LOSS OF POWER. ADDITIONALLY, LOG FILE ANALYSIS REVEALED A LOW FLOW ALARM LOGGED ON 26-JUL-2021 AT 11:39:08. THIS WAS FOLLOWED BY A VAD DISCONNECT ALARM LOGGED ON 26-JUL-2021 AT 11:49:06, INDICATING A PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. NO ADDITIONAL DATA WAS RECORDED FOLLOWING THE VAD DISCONNECT ALARM UNTIL 16-AUG-2021. DURING A CONTROLLER LOSS OF POWER, THE CONTROLLER DISPLAY WILL BE BLANK; THE PUMP STOP DURING THE CONTROLLER LOSS OF POWER EVENT LIKELY CORRESPONDS WITH THE REPORTED VAD STOP EVENT. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF THE ONE ATTACHED POWER SOURCE OR AN INABILITY OF THE ONE CONNECTED BATTERY TO PROVIDE POWER. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; POSSIBLE ROOT CAUSES OF A BATTERY NOT PROVIDING POWER CAN BE ATTRIBUTED, BUT NOT LIMITED, TO AN INTERNAL BATTERY COMMUNICATION ERROR, A FAULTY INTEGRATED CIRCUIT, AN IMPROPER WELD, AND/OR A SOLDERING DEFECT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE OBSERVED LOW FLOW EVENT MAY BE ATTRIBUTED, BUT NOT LIMITED, TO POOR VAD FILLING, THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, AND/OR CONSTRICTION AT THE OUTFLOW GRAFT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED VAD DISCONNECT ALARM CAN BE ATTRIBUTED TO THE PHYSICAL DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. ADDITIONAL PRODUCTS: CONTROLLER 2.0 (B)(6) D9: YES, RETURN DATE: 20-AUG-2021 H3: YES DEV RTN TO MFR? YES H6: IMG CODE(S): G04034 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C15 H6: FDA CONCLUSION CODE(S): D15, D11 UNKNOWN BATTERY H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 UNKNOWN BATTERY H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-OCT-2018 / SERIAL #: (B)(6) UDI #: (B)(4) D9: YES, RETURN DATE: 20-AUG-2021 H3: YES DEV RTN TO MFR? YES H4: MFG DATE: 19-OCT-2017 H5: NO H6: PATIENT IME CODE(S): E2402 H6: IMF CODE(S): F02 H6: IMG CODE(S): G02002, G04035, G0201402, G02002 H6: FDA DEVICE CODE(S): A0708 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C020701, C19, C07, C15 H6: FDA CONCLUSION CODE(S): D02, D1105, D11 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.

Additional Manufacturer Narrative · 0

A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. NEWLY RECEIVED INFORMATION PROVIDED THE CONTROLLER SERIAL NUMBER. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-OCT-2018 / SERIAL #: (B)(6) UDI #: (B)(4) H4: MFG DATE: 31-OCT-2017 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.

Description of Event or Problem · 0

IT WAS FURTHER REPORTED THAT AN ADDITIONAL CONTROLLER WAS RETURNED TO THE MANUFACTURER DUE TO THE PATIENT'S DEATH. THE CONTROLLER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

Additional Manufacturer Narrative · 1

INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM CONTROLLER, MODEL #: UNK / CATALOG #: UNK / EXPIRATION DATE: UNK / SERIAL OR LOT#: UNK UDI #: ASKU, DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: UNK, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MODEL #: UNK / CATALOG #: UNK / EXPIRATION DATE: UNK / SERIAL OR LOT#: UNK, UDI #: ASKU, DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: UNK, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY, MODEL #: UNK / CATALOG #: UNK / EXPIRATION DATE: UNK / SERIAL OR LOT#: UNK, UDI #: ASKU, DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: UNK, LABELED FOR SINGLE USE: NO (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD AND THE VENTRICULAR ASSIST DEVICE (VAD) WAS STOPPED DUE TO UNKNOWN REASON. IT WAS REPORTED THAT THE CONTROLLER DISPLAY WAS BLANK AND TWO BATTERIES WERE CONNECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1177220	HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP	VENTRICULAR (ASSISST) BYPASS	DSQ	HEARTWARE, INC.	1103		00888707000017

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR	Male	Death