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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524INT
Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/24/2021
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient had their log files reviewed to check the function of the rvad (right ventricular assist device). The log file contained multiple sustained low flow hazard alarms as well as low speed advisories. Per the conversation with tech services and the vad coordinator, the patient may have had an inflow mal-positioning which contributed to the low flow. A procedure was performed in an attempt to correct the mal-positioning. The low speed advisories where the result of the set speed being lowered below the low limit and resolved one the set speed was increased. The pump appeared to be operating as intended when sufficient volume was available. The patient was continued to be monitored. It was reported that the patient returned to the operating room for bleeding, 5 liters of blood were evacuated from the patient's chest. It was noted that the pump was not re-positioned. The patient was sedated and ventilated, the notes say the patient had fluid. The patient had routine care which is ongoing. The patient was noted to be stable with no further low flow alarms. The patient required a vats(video-assisted thoracoscopic surgery) on (b)(6) 2021 for a 500ml collection of clot/blood on his right side chest. No additional information was provided.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key11637519
MDR Text Key244662565
Report Number2916596-2021-02007
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/22/2022
Device Model Number106524INT
Device Lot Number7716600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1
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