MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-30 for HEARTMATE 3 SYSTEM CONTROLLER 106531INT manufactured by Thoratec Corporation.
[187038552]
Manufacturer investigation conclusion: the reported events of low volume alarms, line in the lcd, and power cable disconnects were confirmed via the log file; however, the power cable disconnects were routine. A review of the downloaded log file showed 256 events spanning approximately 9 days ((b)(6) 2019 per time stamp). There are only routine power cable disconnect alarms active throughout the log file. No unusual events were observed. The returned system controller, serial (b)(4), was functionally tested and able to support pump function for an extended period of time. Following functional testing, the self-test was performed, and the volume of the alarms was low. Visual inspection revealed debris in the rear speaker which affected the noise level. The controller alarmed at ~82db which is below specification. The speakers were cleaned and the controller alarmed at ~90db which is within specification. The lcd screen from the controller was swapped with a functional lcd. The lcd functioned as intended without any issues. The root cause of the reported low volume was determined to be user error by getting debris in the controller speakers. A root cause for the reported power cable disconnects and line in the lcd was not conclusively determined through this analysis. No further information was provided. The manufacturer is closing the file on this event.
Patient Sequence No: 1, Text Type: N, H10
[187038553]
It was reported that the patient was unable to hear alarms due to a very low volume from system controller. The patient experienced several power disconnect advisory alarms. It was also reported there was a line through the screen of the system controller. The primary controller was exchanged. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01464 |
| MDR Report Key | 9900541 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2017-12-21 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BOB FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528204 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE 3 SYSTEM CONTROLLER |
| Generic Name | VENTRICULAR (ASSISST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 106531INT |
| Catalog Number | 106531INT |
| Lot Number | 6405810 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |