MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Model Number	106762
Medical Device Problem Codes	Decreased Pump Speed (1500); Pumping Stopped (1503); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient changed their controller on (b)(6) 2021 after having alarms at home.
Event or Problem Description
It was reported that the patient changed their controller on (b)(6) 2021 after hearing alarms at home.
Additional Manufacturer Narrative
Section d4: the serial number, lot number, and expiration date are unknown.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report that the patient experienced alarms associated with pump stops was confirmed via the evaluation of heartmate ii lvas, serial number (b)(6) related manufacturer report number: 2916596-2021-01395).Evaluation of (b)(6) identified a compromised driveline that would have contributed to the reported pump stops and low speed events recorded in the log files.The log files provided for review captured multiple episodes of pump speed drops below the low speed limit and motor stop alarms while the patient was supported by both the power module and batteries.The pump stops were accompanied by low speed events as low as 0 rpm and power elevations as high as 18 watts.The heartmate ii system controller used at the time of the reported alarm events was not returned for evaluation.As a result, the cause of the event could not be correlated to the system controller.Attempts were made to obtain additional information such as the controller serial number that was used at the time of the event and the return status of the device; however, no additional information has not been provided at this time.To the date, the system controller (serial number unknown) associated with this complaint is unavailable for analysis.As a result, this complaint file will be closed with no further actions.If the product is returned in a later time, the complaint file will be re-opened.The serial number or other identifying information of the product was not reported and was not able to be determined during the investigation.Heartmate ii patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate ii instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the no external power, low voltage advisory/hazard, low speed, pump off, and low flow alarms, and the actions to take if the alarms cannot be resolved.Heartmate ii patient handbook and heartmate ii instructions for use (ifu) caution users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11563944
• Report Number: 2916596-2021-01704
• Device Sequence Number: 19879372
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/16/2022
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 7047099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/20/2021; 06/17/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/20/2021; 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 105