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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 106524US
Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that a log file review was requested for a patient experiencing many low flow alarms on (b)(6) 2020. There were more reported low flow alarms on (b)(6) 2020 but upon interrogation the vad coordinator could not find any due to pages of pi events. The patient was admitted for the report of multiple low flow alarms. During the analysis of the log technical services observed low flows with high pi readings, these seemed to be physiological in nature. There were no other unusual events seen within the log file. It was reported that the patient was having intermittent low flow alarms but was asymptomatic since the date of implant. Echo, right heart catheterization (rhc) and ramp study were all completed without any abnormal findings. The patient's diuretics were decreased, optimized anti-hypertensives and speed adjusted per results of ramp study. The cause for low flow alarms was identified as inflow canula malposition, as all underlying physiological reasons for low flow have been ruled out. The center requested two hm3 low flow controllers.
 
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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 Key10283332
MDR Text Key201343271
Report Number2916596-2020-03484
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/29/2022
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number6905605
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 Received10/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 07/16/2020 Patient Sequence Number: 1
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