HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0
Report
- Report Number
- 3007042319-2017-02735
- Event Type
- Malfunction
- Date Received
- August 18, 2017
- Date of Event
- July 23, 2017
- Report Date
- March 29, 2019
- Manufacturer
- HEARTWARE
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
CORRECTED: B3: ADDITIONAL DEVICES: BATTERY BAT200503. H6: FDA DEVICE CODE: C133517. BATTERY BAT206189. H6: FDA DEVICE CODE: C133517 BATTERY BAT206468. H6 :FDA DEVICE CODE: C133517 BATTERY BAT206818. H6: FDA DEVICE CODE: C133517 BATTERY BAT210091. H6: FDA DEVICE CODE: C133517. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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: IN ADDITION, ANALYSIS OF THE CONTROLLER LOG FILES REVEALED A CONTROLLER POWER-UP EVENT ON JULY 23, 2017 AT 05:19:34. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE (1) WITH 96% RELATIVE STATE OF CHARGE (RSOC) AND (B)(4) WAS CONNECTED TO POWER PORT TWO (2) WITH 69% RSOC. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT AN AC ADAPTER WAS CONNECTED TO POWER PORT ONE (1) AND (B)(4) WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR A MAXIMUM OF 5 MINUTES AND 2 SECONDS. A SECOND CONTROLLER POWER-UP EVENT WAS OBSERVED ON JULY 24, 2017 AT 18:00:18. THE DATA POINT PRIOR TO THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE (1) WITH 50% RSOC AND (B)(4) WAS CONNECTED TO POWER PORT TWO (2) WITH 96% RSOC. THE DATA POINT RECORDED AFTER THE LOSS OF POWER REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT ONE (1) AND (B)(4) WAS CONNECTED TO POWER PORT TWO (2). THE CONTROLLER WAS WITHOUT POWER FOR A MAXIMUM OF 6 MINUTES AND 16 SECONDS. NO ANOMALIES WERE OBSERVED DURING THE RECORDED CONTROLLER POWER-UPS. AS A RESULT, THE REPORTED CONTROLLER LOSSES OF POWER EVENTS WERE CONFIRMED. A POSSIBLE ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. ADDITIONAL PRODUCTS: (B)(4). 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.
CORRECTION: PRODUCT EVENT SUMMARY: THE CONTROLLER ((B)(4)) AND FIVE BATTERIES ((B)(4)) WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE CONTROLLER AND BATTERIES¿ MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED THE SOFTWARE MASTER RECORD (SMR) SOFTWARE. THE SOFTWARE UPGRADE CONTAINS 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 (B)(4). THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION IS EVALUATING MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: BATTERY (B)(4) UDI#: ASKU, MFG DATE: 2014-09-30. BATTERY (B)(4) UDI#: ASKU, MFG DATE: 2015-04-30. BATTERY (B)(4) UDI#: ASKU, MFG DATE: 2015-04-30. BATTERY (B)(4) UDI#: ASKU, MFG DATE: 2015-04-30. BATTERY (B)(4) UDI#: ASKU, MFG DATE: 2015-10-31. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS ALSO REPORTED THAT THE CONTROLLER LOST POWER TWICE, RESULTING IN TWO VENTRICULAR ASSIST DEVICE (VAD) STOPS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. ADDITIONAL DEVICES: (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 30-SEP-2015, DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. BATTERY ISSUE. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 30-APR-2016, DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. BATTERY ISSUE. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 30-APR-2016, DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. BATTERY ISSUE. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 30-SPR-2016, DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. BATTERY ISSUE. (B)(4) - BATTERY / CATALOG NUMBER 1650DE / EXPIRATION DATE: 31-OCT-2016, DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, PRODUCT NOT RECEIVED - NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE: NO. BATTERY ISSUE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
IT WAS REPORTED BY THE PATIENT THAT THERE WAS POWER SWITCHING, WHICH WAS CONFIRMED BY THE SURGEON. THE CONTROLLER AND BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584163 | HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0 | CIRCULATORY ASSIST SYSTEM | DSQ | HEARTWARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |