HEARTWARE VENTRICULAR ASSIST SYSTEM
Report
- Report Number
- 3007042319-2017-04058
- Event Type
- Malfunction
- Date Received
- November 16, 2017
- Date of Event
- September 28, 2017
- Report Date
- October 23, 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
- PHYSICIAN
Narratives
THIS REPORT WAS IDENTIFIED FOLLOWING THE CONVERSION OF COMPLAINT FILES FROM THE LEGACY COMPLAINT HANDLING SYSTEM FOLLOWING INTEGRATION AND IS BEING SUBMITTED TO REPORT ANALYSIS RESULTS. PRODUCT EVENT SUMMARY: THE RETURNED CONTROLLER PASSED VISUAL AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. ADDITIONAL DEVICE(S) INVOLVED IN EVENT: D4: BATTERY / (B)(4) H3: YES ¿ RETURNED TO MANUFACTURER 2017-11-15 H6. METHOD CODE(S): 10, 23, 38, 3372 H6. RESULT CODE(S): 3213 H6. CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. D4: BATTERY / (B)(4) H3: YES ¿ RETURNED TO MANUFACTURER 2017-11-15 H6. METHOD CODE(S): 10, 23, 38, 3372 H6. RESULT CODE(S): 3213 H6. CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. D4: BATTERY / (B)(4).H3: YES ¿ RETURNED TO MANUFACTURER 2017-11-15 H6. METHOD CODE(S): 10, 23, 38, 3372 H6. RESULT CODE(S): 3213 H6. CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. D4: BATTERY / (B)(4). H3: YES ¿ RETURNED TO MANUFACTURER 2017-11-15 H6. METHOD CODE(S): 10, 23, 38, 3372 H6. RESULT CODE(S): 213 H6. CONCLUSION CODE(S): 71 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. D4: BATTERY / (B)(4). H3: YES ¿ RETURNED TO MANUFACTURER 2017-11-15 H6. METHOD CODE(S): 10, 23, 38, 3372 H6. RESULT CODE(S): 3213 H6. CONCLUSION CODE(S): 25 PRODUCT EVENT SUMMARY: THE BATTERY PASSED VISUAL AND FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. 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.
PRODUCT EVENT SUMMARY: ONE CONTROLLER ((B)(4) ) AND FIVE BATTERIES ((B)(4) ) 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 REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS REVEALED THAT THE CONTROLLER PASSED FUNCTIONAL TESTING. VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS SURROUNDING POWER PORT 1 AND POWER PORT 2. AN INTERNAL VISUAL INSPECTION DID NOT REVEAL FLUID INGRESS. THE HAIRLINE CRACKS ARE NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED, 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. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER ((B)(4) ) CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. REVIEW OF THE CONTROLLER LOG FILES REVEALED THREE (3) CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4) . ANALYSIS OF THE DATA LOG FILES ALSO REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4) . AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. MANUFACTURER IS INVESTIGATING MOMENTARY DISCONNECTIONS. 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.
ONE CONTROLLER ((B)(4)) AND FIVE BATTERIES ((B)(4)) 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 CONTROLLER AND BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. 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. REVIEW OF THE CONTROLLER LOG FILES REVEALED THREE (3) CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). ANALYSIS OF THE DATA LOG FILES ALSO REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION IS EVALUATING MOMENTARY DISCONNECTIONS. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE CONTROLLER INTERMITTENT DISCONNECTIONS. 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.
OTHER DEVICES INVOLVED IN THIS EVENT: MEDICAL DEVICE: BATTERY / (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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. BATTERY/ (B)(4)/ CAT#1650DE / EXP. DATE: 04/30/2017. (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATED BY MANUFACTURER: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG. DATE: 05/01/2016. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4)/ CAT#1650DE / EXP. DATE: 03/31/2017. (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATED BY MANUFACTURER: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG. DATE: 04/01/2016. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4)/ CAT#1650DE / EXP. DATE: 03/31/2017. (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATED BY MANUFACTURER: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG. DATE: 04/01/2016. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4)/ CAT#1650DE / EXP. DATE: 03/31/2017. (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATED BY MANUFACTURER: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG. DATE: 04/01/2016. LABELED FOR SINGLE USE: NO. (B)(4). BATTERY/ (B)(4)/ CAT#1650DE / EXP. DATE: 03/31/2017. (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE EVALUATED BY MANUFACTURER: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG. DATE: 04/01/2016. LABELED FOR SINGLE USE: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED BY THE PATIENT THAT THEY HAD SEVERAL CRITICAL BATTERY ALARMS AND POWER SWITCHING WAS CONFIRMED. ALL BATTERIES AND THE CONTROLLER WERE EXCHANGED AND THE PATIENT HAD NO ISSUES. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816852 | HEARTWARE VENTRICULAR ASSIST SYSTEM | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420-MCS | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN MCS VAD |