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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Encephalopathy (1833); High Blood Pressure/ Hypertension (1908); Septic Shock (2068); Hemorrhagic Stroke (4417); Unspecified Mental, Emotional or Behavioural Problem (4430)
Event Date 05/16/2022
Event Type  Death  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
Related manufacturer report number: 2916596-2022-11139. It was reported that the patient presented to the emergency department (ed) with altered mental status. A computerized tomography scan was performed indicating no signs of bleeding. The patient's initial lab work showed the patient international normalized ratio (inr) was 8. 5 with a hemoglobin (hgb) level of 4. 5. They received a transfusion of 1 unit of blood after which their hb dropped to 8. These results were thought to be highly suspicious and inaccurate. The labs were repeated. On interrogation of the patient's system controller. It was discovered that the patient had a low flow alarm on (b)(6) 2022 at 1522. The patient had a history of many pulsatility index (pi) events. Of note the patient's fluctuating volume status correlate with the patient's dialysis treatment. Additionally, a no external power alarm occurred in the clinic during power source exchange. A review of the log files revealed persistent pi events throughout the log. A low voltage hazard/ no external power event occurred on (b)(6) 2022 at 1427 while the patient was on the mobile power unit (mpu). The mpu lost total power enabling the backup battery in the controller until power was restored to the mpu. The total event lasted about 8 seconds. A lone low flow event occurred on (b)(6) 2022 at 1522.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (ASSIST) 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 Key14566727
MDR Text Key293101602
Report Number2916596-2022-11181
Device Sequence Number1
Product Code DSQ
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8089761
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2021
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: 06/01/2022 Patient Sequence Number: 1
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