HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2018-01429
- Event Type
- Malfunction
- Date Received
- April 12, 2018
- Date of Event
- March 6, 2018
- Report Date
- August 20, 2019
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000017
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-0067-2019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: ONE (1) CONTROLLER ((B)(4)) WAS RETURNED FOR EVALUATION. ONE (1) HVAD PUMP ((B)(4)) AND EIGHT (8) BATTERIES ((B)(4)) WERE NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE CONTROLLER IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER ((B)(4)) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING; THE BATTERIES WERE ABLE TO ADEQUATELY CONNECT TO THE CONTROLLER. AS A RESULT, THE REPORTED POOR MECHANICAL CONNECTION EVENT COULD NOT BE CONFIRMED. VISUAL INSPECTION OF CONTROLLER UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK AROUND POWER PORT 2. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK WAS NOT RELATED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION CONDUCTED UNDER (B)(4), THE ROOT CAUSE OF THE HAIRLINE CRACK WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENT STRESS CRACKING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, CON305563, CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE ALARM LOG FILES REVEALED TWO (2) CRITICAL BATTERY ALARM DUE TO COMMUNICATION ERRORS INVOLVING (B)(4). ONE (1) VAD DISCONNECT ALARM WAS LOGGED ON MARCH 19, 2018. NO LOW FLOW ALARMS HAVE BEEN LOGGED WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED "CRITICAL BATTERY ALARM" AND "VAD STOP" EVENT WAS CONFIRMED; HOWEVER, THE REPORTED "LOW FLOW ALARM" EVENT COULD NOT BE CONFIRMED. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL MOMENTARY DISCONNECTIONS INVOLVING (B)(4). MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE "TONE/BEEP". AS A RESULT, THE REPORTED "BEEPS" EVENT WAS C ONFIRMED. ANALYSIS OF EVENT LOG FILES REVEALED SEVERAL CONTROLLER POWER UP EVENTS WITHIN THE ANALYZED PERIOD. FURTHERMORE, THERE WERE MOMENTARY DISCONNECTIONS RECORDED PRIOR TO SEVERAL OF THE CONTROLLER POWER UP EVENTS. AS A RESULT, THE REPORTED "LOSS OF POWER" EV ENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED TO A COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE "VAD STOP" EVENT CAN BE ATTRIBUTED TO THE DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER DURING CONTROLLER EXCHANGE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED "BEEPING" CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. A POSSIBLE ROOT CAUSE OF THE REPORTED 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. CONTORLLER 2.0 (B)(4), D4: EXPIRATION DATE: 2018-05-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2017-05-31, H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 18,0 H6 FDA CONCLUSION CODE(S): 12 D4: BATTERY (B)(4,) D4: EXPIRATION DATE: 2017-01-31 UDI #: (B)(4) D10: NO H4: MFG DATE: 2016-01-31, H3: YES, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12, D4: BATTERY (B)(4), D4: EXPIRATION DATE: 2017-12-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2016-12-31, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12, D4: BATTERY (B)(4), D4: EXPIRATION DATE: 2017-12-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2017-05-31, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12 BATTERY (B)(4), D4: EXPIRATION DATE: 2017-01-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2016-01-31, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12, D4: BATTERY (B)(4), D4: EXPIRATION DATE: 2017-01-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2016-01-31, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12, D4: BATTERY (B)(4), D4: EXPIRATION DATE: 2017-01-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2016-01-31, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12, D4: BATTERY / (B)(4), D4: EXPIRATION DATE: 2017-01-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2016-01-31, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12, D4: BATTERY / (B)(4), D4: EXPIRATION DATE: 2017-01-31 UDI #: (B)(4), H3: YES H4: MFG DATE: 2016-01-31, H6 FDA METHOD CODE(S): 4114, 4112, H6 FDA RESULTS CODE(S): 3213, H6 FDA CONCLUSION CODE(S): 12 CORRECTION: H10, D4 FOR BATTERY PRODUCTS. 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.
CORRECTION: DISREGARD (B)(4), (B)(4). 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 (1) CONTROLLER WAS RETURNED FOR EVALUATION. ONE (1) VENTRICULAR ASSIST DEVICE (VAD) AND EIGHT (8) BATTERIES ((B)(6) ) WERE NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE CONTROLLER IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING; THE BATTERIES WERE ABLE TO ADEQUATELY CONNECT TO THE CONTROLLER. AS A RESULT, THE REPORTED POOR MECHANICAL CONNECTION EVENT COULD NOT BE CONFIRMED. VISUAL INSPECTION OF CONTROLLER UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK AROUND POWER PORT TWO (2). AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK WAS NOT RELATED TO THE REPORTED EVENT. BASED ON AN INTERNAL INVESTIGATION, THE ROOT CAUSE OF THE HAIRLINE CRACK WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENT STRESS CRACKING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE ALARM LOG FILES REVEALED SEVERAL CRITICAL BATTERY ALARMS DUE TO COMMUNICATION ERRORS INVOLVING BATTERIES (B)(6) . ONE (1) VAD DISCONNECT ALARM WAS LOGGED ON (B)(6) 2018. NO LOW FLOW ALARMS HAVE BEEN LOGGED WITHIN THE ANALYZED PERIOD. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL MOMENTARY DISCONNECTIONS INVOLVING (B)(6) . MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE "TONE/BEEP". DATA LOG FILES ALSO REVEALED MULTIPLE INSTANCES INVOLVING (B)(6) WHERE THE BATTERIES¿ RELATIVE STATE OF CHARGE (RSOC) WAS BETWEEN 101-201, WHICH ARE INDICATIVE OF COMMUNICATION ERRORS. ANALYSIS OF EVENT LOG FILES REVEALED SEVERAL CONTROLLER POWER UP EVENTS WITHIN THE ANALYZED PERIOD. FURTHERMORE, THERE WERE MOMENTARY DISCONNECTIONS RECORDED PRIOR TO SEVERAL OF THE CONTROLLER POWER UP EVENTS. AS A RESULT, THE REPORTED CRITICAL BATTERY ALARMS, "VAD STOP", "BEEPS", LOSSES OF POWER AND COMMUNICATION ERROR EVENTS WERE CONFIRMED; HOWEVER, THE REPORTED LOW FL OW ALARMS COULD NOT BE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED TO A COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BAT TERIES. THE MOST LIKELY ROOT CAUSE OF THE "VAD STOP" EVENT CAN BE ATTRIBUTED TO THE DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER DURING CONTROLLER EXCHANGE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED "BEEPING" CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. A POSSIBLE ROOT CAUSE OF THE REPORTED LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. POSSIBLE ROOT CAUSES OF THE REPORTED COMMUNICATION ERRORS CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS ON THE COMMUNICATION PINS OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERY, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. AN INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: D4: CATALOG #: 1420 / SERIAL #: (B)(6) H3: YES H6: FDA CONCLUSION CODE(S): 4307 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650 / CATALOG #: 1650/ EXPIRATION DATE: 31-JAN-2017 / SERIAL #: (B)(6) UDI #: (B)(4) D10: NO H3: YES DEV RTN TO MFR? YES H4: MFG DATE: 31-JAN-2016 H5: NO H6: PATIENT CODE(S): C76143 H6: DEVICE CODE(S): C63030 H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 12 D4: CATALOG #: 1650 / SERIAL #: (B)(6) H3: YES D4: CATALOG #: 1650 / SERIAL #: (B)(6) H3: YES H4: MFG DATE: 31-DEC-2015 H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650 / SERIAL #: (B)(6) H3: YES H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650/ SERIAL #: (B)(6) H3: YES D4: CATALOG #: 1650 / SERIAL #: (B)(6) H3: YES H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650 / SERIAL #: (B)(6) H3: YES H6: FDA CONCLUSION CODE(S): 4307 D4: CATALOG #: 1650 / SERIAL #: (B)(6) H3: YES H6: FDA CONCLUSION CODE(S): 4307. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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.
THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF LOG FILE DATA. 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.
IT WAS FURTHER REPORTED THAT THAT VAD EXPERIENCED SEVERAL VAD STOPS.
LOG FILE REVIEW INDICATED THAT TWO OF THE BATTERIES ALSO HAD A COMMUNICATION ERROR.
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 ¿CONTROLLER 2.0. CONTORLLER 2.0 / (B)(4) / MODEL #: 1420 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). RETURN DATE: 2018-04-04: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY/ (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). MFG DATE: 2017-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY/ (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). MFG DATE: 2017-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). MFG DATE: 2017-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). MFG DATE: 2017-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-05-31. UDI #: (B)(4). MFG DATE: 2017-05-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-12-31. UDI #: (B)(4). MFG DATE: 2017-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-12-31. UDI #: (B)(4). MFG DATE: 2017-12-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY. BATTERY / (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-12-31. UDI #: (B)(4). MFG DATE: 2017-12-31. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOW ALARMS. THE CONTROLLER AND BATTERIES EXHIBITED CRITICAL BATTERY ALARMS AND POOR MECHANICAL CONNECTIONS. THE PATIENT FELT THE VAD WOULD STOP WHEN CHANGING THE BATTERIES ON THE CONTROLLER. THE CONTROLLER HAS LOST POWER AND EXPERIENCED DOUBLE DISCONNECT EVENTS POSSIBLY LINKED TO DAMAGE OF THE CONTROLLER. THE VAD REMAINS IN USE, 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 |
|---|---|---|---|---|---|---|---|
| 267914 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707000017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |