HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

Report

Report Number: 3007042319-2018-03207
Event Type: Malfunction
Date Received: July 24, 2018
Date of Event: June 30, 2018
Report Date: December 11, 2018
Manufacturer: HEARTWARE, INC.
Product Code: DSQ
UDI-DI: 00888707000420
PMA / PMN Number: P100047
Removal / Correction Number: Z-1903-2018
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

PRODUCT EVENT SUMMARY: THE CONTROLLER AND EIGHT BATTERIES WERE RETURNED FOR EVALUATION. FAILURE ANALYSIS OF THE RETURNED CONTROLLER AND SIX OF THE BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE REMAINING BATTERIES (BAT214169 AND BAT219444) REVEALED THAT THE UNITS PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED THAT THE BATTERY CONNECTOR RELEASE INDICATORS WERE ILLEGIBLE. THIS IS AN ADDITIONAL FINDING, NOT RELATED TO THE REPORTED EVENT, LIKELY DUE TO WEAR AND/OR HANDLING OF THE DEVICES. 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 BAT585377, BAT585370, BAT580663, BAT219444, BAT218240, BAT214169, AND BAT210075 WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE MOMENTARY DISCONNECTIONS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. ADDITIONAL PRODUCTS: BATTERY, BAT214169 H3: YES H6 FDA METHOD CODE(S): 10, 4112. FDA RESULTS CODE(S): 135, 3213. FDA CONCLUSION CODE(S): 12, 19 BATTERY, BAT580663 H3: YES. FDA METHOD CODE(S): 10, 4112. FDA RESULTS CODE(S): 3213. FDA CONCLUSION CODE(S): 12 BATTERY, BAT202000 H3: YES H6 FDA METHOD CODE(S): 10, 4112. FDA RESULTS CODE(S): 213. FDA CONCLUSION CODE(S): 67 BATTERY, BAT218240 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213. FDA CONCLUSION CODE(S): 12 BATTERY, BAT219444 H3: YES. FDA METHOD CODE(S): 10, 4112. FDA RESULTS CODE(S): 135, 3213 H6 FDA CONCLUSION CODE(S): 12, 19 BATTERY, BAT585370 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY, BAT585377 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 BATTERY, BAT210075 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213. FDA CONCLUSION CODE(S): 12 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.

Additional Manufacturer Narrative · 1

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 / EXPIRATION DATE: 2017-02-28 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-02-28 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-05-31 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2015-10-31 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2014-10-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-05-31 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2016-10-31 UDI #: (B)(4) RETURN DATE: 2018-07-09 DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2015-10-31 (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 EXPERIENCING POWER SWITCHING WHILE AT HOME. THE SITE FURTHER NOTED THAT THE CHARGE ON THE BATTERIES DURING THE SWITCHING EVENTS WAS GREATER THAN TWENTY-FIVE PERCENT. THE DEVICES HAVE BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
557230	HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0	VENTRICULAR (ASSISST) BYPASS	DSQ	HEARTWARE, INC.	1420		00888707000420

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR			MCS UNKNOWN VAD