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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS
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THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106762
Device Problems Disconnection (1171); Electrical Power Problem (2925); Material Deformation (2976); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient presented on (b)(6) 2022 with initially beeping and then continuous alarms that woke them up.These alarms recurred while at the rehabilitation gym.Their connections were tightened which resolved the alarms both times.The patient was asymptomatic.Log files revealed multiple power cable disconnects while using the mobile power unit and battery power.On (b)(6) 2021 a backup battery fault alarm was noted.A no external power event was noted on (b)(6) 2022 at 04:49 that appeared to be due to the patient simultaneously disconnecting power from both controller leads.The patient's controller was exchanged.
 
Event Description
It was reported that the patient presented on (b)(6) 2022 with initially beeping and then continuous alarms that woke them up.These alarms recurred while at the rehabilitation gym.Their connections were tightened which resolved the alarms both times.The patient was asymptomatic.Log files revealed multiple power cable disconnects while using the mobile power unit and battery power.On (b)(6) 2021 a backup battery fault alarm was noted.A no external power event was noted on (b)(6) 2022 at 04:49 that appeared to be due to the patient simultaneously disconnecting power from both controller leads.The patient's controller was exchanged.
 
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was noted that the account suspected an issue with the wiring in the system controller power leads due to the way the patient wears the 14v batteries and vest.
 
Manufacturer Narrative
Section b5: the backup battery fault alarm on 14dec2021 and no external power event on 23jan2022 were deemed non-reportable and inadvertently included in the previous report.This report was intended to capture the 24jan2022 system controller exchange due to atypical power cable disconnects and suspected power cable damage.Manufacturer's investigation conclusion: the reported events of power cable disconnect and no external power alarms was confirmed via the provided log file.The log file contained data spanning approximately 46 days (09dec2021 ¿ 24jan2022 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.A few atypical power cable disconnect alarms (alarms not associated with a power source exchange) were intermittently observed throughout the data, and each alarm appeared to have resolved within the next recorded event.A no external power alarm was also observed on 23jan2022 at 4:49.The alarm appeared to have been caused by disconnections of both power cables, and the alarm resolved within the next recorded event when power was restored to the system.No other notable events were observed.The returned system controller (serial number (b)(6) was functionally tested and operated a mock loop as intended throughout all testing.Atypical alarms were unable to be reproduced, even when the controller¿s power cables were manipulated by hand.The root cause of the reported power cable disconnect alarms was unable to be conclusively determined.The root cause of the observed no external power alarm appeared to have been disconnections of both power cables from external power.During the investigation wire fatigue was observed within controller¿s black power cable.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate ii patient handbook (rev.F, section 2 ¿how your heart pump works¿) instructs users that the 11-volt backup battery should only be used as temporary support in a power loss emergency.Inappropriate use of the backup battery may result in diminished runtime during a power loss emergency.The heartmate ii patient handbook (rev.F, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s power cords, and to obtain replacements if needed.The heartmate ii patient handbook (rev.F, section 5 ¿alarms and troubleshooting¿) describes all alarms (visual and audible) and what action should be performed when they do occur, including alarms associated with power cable disconnect and no external power alarm conditions: to resolve the no external power alarm: 1.Immediately connect the system controller power cables to a working power source (functioning mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.Call your hospital contact immediately if connecting to power does not resolve the alarm.The heartmate ii patient handbook (rev.F, section titled ¿emergency contact list¿) cautions 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.
 
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Brand Name
HEARTMATE II SYSTEM CONTROLLER
Type of Device
VENTRICULAR (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 Key13481820
MDR Text Key285480132
Report Number2916596-2022-00558
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011286
UDI-Public813024011286
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/10/2022
Device Model Number106762
Device Lot Number7125922
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
Patient Weight93 KG
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