MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106762

Device Problems Alarm Not Visible (1022); Disconnection (1171); Mechanical Problem (1384)

Patient Problems Memory Loss/Impairment (1958); Sleep Dysfunction (2517); Ischemia Stroke (4418); Fecal Incontinence (4571); Urinary Incontinence (4572); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

It was reported that the patient was admitted due to stroke like symptoms.The patient reported that they had slept for nearly 24hr prior to coming in, and upon waking, they had urinated and defecated on themselves.It was reported that the patient's battery power was very low and that they were hooked up to the power module upon arrival to the hospital.Under interrogation it was found that there were multiple low voltage advisories and clock not set recordings.The controller was not alarming at the time it was hooked up to the power module.Confirmation that the pump was on by looking at the controller was not done as it wasn't alarming and it was in the patient's shoulder bag.It was not confirmed if the pump was off due to depleted power or for how long it was off for.Log file review did not show a pump off, however the date and time did reset to defaults.This could've possibly resulted from a double power cable disconnect or the batteries being completely depleted and the ebb (backup battery) being drained.The time and date were corrected on (b)(6) 2022 at 4:51.Related heartmate ii pump manufacturer report: 2916596-2022-10276.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

B1: adverse event was selected inadvertently in the previous report b2: hospitalization, life threatening, and required to prevent permanent impairment/damage were selected inadvertently in the previous report manufacturer's investigation conclusion: the device history records were reviewed and the records revealed the heartmate iii system controller (serial#: (b)(6) was manufactured in accordance with manufacturing and qa specifications.Heartmate ii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms.Heartmate ii instructions for use section 3 ¿ ¿powering the system¿ and heartmate ii patient handbook section 3 ¿ ¿powering the system¿ addresses the user to not use expired batteries and advises the user to properly dispose of them.The patient handbook cautions the 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.The reported event of the controller failing to alarm was not confirmed.The reported damage to the black power cable connector was not confirmed.The heartmate ii system controller (serial #: (b)(6) was not returned for analysis and a log file was submitted for review spanning approximately 2 days (b)(6)2001, (b)(6) 2022 per timestamp).Events occurring on (b)(6) 2001 are from when the system clock was not set.There were no notable alarms in the log file.Pump operation was not affected.Additional information communicated on 04may2022 indicated that no products would be returning.The root causes of the reported events were unable to be determined in this analysis.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported the system controller was exchanged on 05apr2022 due to damage at the connectors, specifically a cracked black lead connection.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (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 Key: 14164169
• MDR Text Key: 290160161
• Report Number: 2916596-2022-10497
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• 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
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 108 KG