HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP

Report

Report Number: 3007042319-2016-03141
Event Type: Death
Date Received: September 2, 2016
Date of Event: August 25, 2016
Report Date: October 4, 2018
Manufacturer: HEARTWARE, INC
Product Code: DSQ
PMA / PMN Number: P100047
Removal / Correction Number: Z-1538-2017, Z-005-2017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CAC ADAPTER SERIAL: (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICES WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS PRIOR TO RELEASE. LOG FILE ANALYSIS REVEALED THE LAST DATA POINT RECORDED WAS ON (B)(6) 2016 AT 00:51:22. THE LAST DATA POINT DEMONSTRATED THE CONTROLLER BEING POWERED BY (B)(4) WITH 48% RSOC ON PORT 1 AND (B)(4) WITH 96% RSOC ON PORT 2. THE SECOND TO LAST DATA POINT RECORDED AT 00:36:20 DEMONSTRATED THAT THE CONTROLLER WAS BEING POWERED BY A CAC ADAPTER ON PORT 1 AND (B)(4) WITH 50% RSOC ON PORT 2. A CONTROLLER POWER-UP EVENT WAS RECORDED ON (B)(6) 2016 AT 00:55:49 INDICATING A MAXIMUM LOSS OF POWER TO THE CONTROLLER OF APPROXIMATELY 4 MINUTES. A SECOND CONTROLLER POWER-UP WAS RECORDED AT 07:06:08 INDICATING A MAXIMUM LOSS OF POWER TO THE CONTROLLER OF APPROXIMATELY 6 HOURS AND 11 MINUTES. NO ALARMS WERE RECORDED ON OR AROUND THE REPORTED EVENT DATE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A DOUBLE DISCONNECT OF BOTH POWER SOURCES FROM THE CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

Additional Manufacturer Narrative · 1

3007042319-2016-03141, DEVICE AVAILABLE FOR EVAL: 27/JUN/2017. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. 3007042319-2016-03141, DEVICE AVAILABLE FOR EVAL: 27/JUN/2017. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

Additional Manufacturer Narrative · 1

THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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, INCLUDING TRANSPORTATION. THE HVAD CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION: EITHER TWO BATTERIES, OR ONE BATTERY AND AN AC ADAPTER OR DC ADAPTER. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. THEY ALSO OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. IT IS OUTLINED TO INSPECT THE POWER CONNECTIONS AND PINS ONCE A WEEK, ONE AT A TIME WHEN CHANGING THE POWER SOURCE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. THE DEVICE LABELING WARNS THAT DISCONNECTING BOTH POWER SOURCES (BATTERIES AND AC OR DC ADAPTER) AT THE SAME TIME WILL STOP THE PUMP. AT LEAST ONE POWER SOURCE MUST BE CONNECTED AT ALL TIMES. THE IFU FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE DEVICES ARE BEING RETURNED; HOWEVER, IT IS UNKNOWN WHICH OF THESE WERE INVOLVED IN THE EVENT. THESE DEVICES WILL BE ANALYZED AND REPORTED AS REQUIRED. SERIAL # (B)(4), CATALOG # 1407DE, EXP. DATE: 09/30/2016, MFG. DATE: 09/01/2015. (B)(4). SERIAL # UNKNOWN CAC ADAPTER, CATALOG # 1430DE, EXP.DATE: UNK, MFG. DATE: UNK. (B)(4). DEVICE HAS NOT BEEN RECEIVED.

Additional Manufacturer Narrative · 1

HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER 1.0: CONTROLLER/ (B)(4). DEVICE AVAILABLE FOR EVALUATION?: YES, RETURN DATE: 2017-07-03. DEVICE EVALUATED BY MFR?: YES. LABELED FOR SINGLE USE?: NO. HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY: BATTERY / (B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2016-04-30. DEVICE AVAILABLE FOR EVALUATION?: YES, RETURN DATE: 2017-07-26. DEVICE EVALUATED BY MFR?: YES. MFG DATE: 2015-04-30. LABELED FOR SINGLE USE?: NO. HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY: BATTERY / (B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2016-09-30. DEVICE AVAILABLE FOR EVALUATION?: YES, RETURN DATE: 2017-07-26. DEVICE EVALUATED BY MFR?: YES. MFG DATE: 2015-09-30. LABELED FOR SINGLE USE?: NO. HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY: BATTERY / (B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2016-09-30. DEVICE AVAILABLE FOR EVALUATION?: YES, RETURN DATE: 2017-07-26. DEVICE EVALUATED BY MFR?: YES. MFG DATE: 2015-09-30. LABELED FOR SINGLE USE?: NO. HEARTWARE VENTRICULAR ASSIST SYSTEM -BATTERY: BATTERY / (B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2016-09-30. DEVICE AVAILABLE FOR EVALUATION?: YES, RETURN DATE: 2017-07-26. DEVICE EVALUATED BY MFR?: YES. MFG DATE: 2015-09-30. LABELED FOR SINGLE USE?: NO. HEARTWARE VENTRICULAR ASSIST SYSTEM -CAC ADAPTER: CAC ADAPTER/ (B)(4)/ MODEL #: 1430DE. DEVICE AVAILABLE FOR EVALUATION?: YES, RETURN DATE: 2017-07-26. DEVICE EVALUATED BY MFR?: YES. LABELED FOR SINGLE USE?: NO. (B)(4). PRODUCT EVENT SUMMARY: A PUMP, CONTROLLER, FOUR BATTERIES, AND A CAC ADAPTER WERE RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE CONTROLLER AND (B)(4) CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED THE LAST DATA POINT RECORDED WAS ON (B)(6) 2016 AT 00:51:22. THE LAST DATA POINT DEMONSTRATED THE CONTROLLER BEING POWERED BY(B)(4) WITH 48% RSOC ON PORT 1 AND (B)(4) WITH 96% RSOC ON PORT 2. THE SECOND TO LAST DATA POINT RECORDED AT 00:36:20 DEMONSTRATED THAT THE CONTROLLER WAS BEING POWERED BY A CAC ADAPTER ON PORT 1 AND (B)(4) WITH 50% RSOC ON PORT 2. A CONTROLLER POWER-UP EVENT WAS RECORDED ON (B)(6) 2016 AT 00:55:49 INDICATING A MAXIMUM LOSS OF POWER TO THE CONTROLLER OF APPROXIMATELY 4 MINUTES. A SECOND CONTROLLER POWER-UP WAS RECORDED AT 07:06:08 INDICATING A MAXIMUM LOSS OF POWER TO THE CONTROLLER OF APPROXIMATELY 6 HOURS AND 11 MINUTES. NO ALARMS WERE RECORDED ON OR AROUND THE REPORTED EVENT DATE. ADDITIONALLY, LOG FILES ALSO REVEALED SWITCHING EVENTS LOGGED DUE TO MOMENTARY DISCONNECTS INVOLVING BATTERIES (B)(4). THESE ARE INCIDENTAL FINDINGS NOT RELATED TO THE REPORTED EVENT SINCE THEY DID NOT OCCUR ON THE DATE OF THE EVENT. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE MOMENTARY DISCONNECTIONS. FAILURE ANALYSIS OF THE PUMP REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION, DIMENSIONAL VERIFICATION AND FUNCTIONAL TESTING. IN DEPENDENT PATHOLOGY REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE PUMP. THE RETURNED CONTROLLER PASSED FUNCTIONAL TESTING, ELECTRICAL CONNECTIONS BETWEEN THE CONTROLLER AND THE BATTERIES WERE STABLE. VISUAL INSPECTION REVEALED THAT THE POWER PORT 1 CONNECTOR WAS SLIGHTLY LOOSE FROM THE CONTROLLER HOUSING. BASED ON AN INVESTIGATION CONDUCTED, THE MOST LIKELY ROOT CAUSE CAN BE ATTRIBUTED TO INADEQUATE THREAD LOCK, AN INCONSISTENT THREAD LOCK CURE TIME AND AN INADEQUATE TORQUE APPLICATION DURING THE ASSEMBLY PROCESS. THE MANUFACTURER HAS OPENED AN INVESTIGATION WITH THE SUPPLIER TO EVALUATE LOOSE CONNECTORS. FAILURE ANALYSIS OF THE BATTERIES (B)(4) REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS OF (B)(4) REVEALED THAT THE BATTERY PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED THAT THE RELEASE INDICATOR ON THE BATTERY CONNECTOR WAS WORN OUT; THIS CAN BE ATTRIBUTED TO PATIENT USE OR WEAR. (B)(4) PASSED VISUAL INSPECTION BUT FUNCTIONAL TESTING REVEALED A LIFTED CELL WELD. THIS ISSUE IS CURRENTLY INVESTIGATED BY THE MANUFACTURER. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A DOUBLE DISCONNECT OF BOTH POWER SOURCES FROM THE CONTROLLER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

OTHER DEVICES INVOLVED IN THIS EVENT: CONTROLLER / (B)(4); BATTERY / (B)(4); BATTERY / (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS FOUND DEAD ON (B)(6) 2016. THE CONTROLLER WAS NOT OPERATING; ONLY THE AC ADAPTER WAS CONNECTED TO THE CONTROLLER. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
575828	HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP	CIRCULATORY ASSIST SYSTEM	DSQ	HEARTWARE, INC

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death	(B)(4) - BATTERY\| (B)(4) - BATTERY\| (B)(4) - BATTERY\| (B)(4) - BATTERY