MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER; VENTRICULAR (ASSIST) BYPASS

Model Number 1440

Device Problem Fire (1245)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/04/2023

Event Type  Death  

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 passed away on (b)(6) 2023 due to smoke inhalation from a fire.It was indicated that the fire was believed to be caused by one or more of the patient¿s batteries in the universal battery charger.

Event Description

The autopsy report and the final opinion of the medical examiner is as follows, [redacted], died of inhalation of products of combustion.As per investigation, she [sic] was last known alive while texting with family.The next morning, emergency services were contacted by a bystander for a residential fire.He was found unresponsive on the couch.His medical history included hypertensive and atherosclerotic cardiovascular disease with documented heart failure.Postmortem toxicology demonstrated an elevated level of alcohol approximately twice the legal limit with an elevated carboxyhemoglobin (carbon monoxide in the blood) level.Based on information available at this time, the manner of death is certified as accident.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the universal battery charger (ubc), batteries, and the reported event was not able to be determined.The universal battery charger, serial number (b)(6) was not available for evaluation.No product has been returned to abbott for investigation and the equipment is in the family¿s possession at this time.Visual inspection of abbott equipment was completed in the presence of abbott legal counsel (at a location outside of abbott).No conclusions were drawn about the origin of the fire based on this inspection.Abbott continues to try and obtain additional information and product return to aid in our root cause investigation.Based on the information provided at this time, no conclusions regarding the source of the fire have been made.Photos provided by the fire expert retained by abbott where reviewed.The provided photos revealed a significant thermal damage to slots 3 and 4 (back side of the unit) and the batteries in these slots.The front side of the unit (user interface panel and slots 1 and 2) appeared intact.The photos of the batteries in slot 1 and 2 revealed damaged housings; however, the contacts and the batteries fuel gauges appeared intact.The ubc and remaining 14v batteries in the ubc were located at the periphery of the fire and were damaged as a result of the fire.The ubc and 14v battery designs include protection/safety electronics and are constructed with ul safety rated materials to meet state-of-the-art electrical safety and battery safety standards.Abbott legal counsel has been collaborating with the patient¿s family attorney to obtain additional information regarding this matter.Both abbott and the family have consulted fire experts and there have been multiple reviews to date.Abbott has received the fire department¿s report regarding its response to the fire, however the report draws no conclusions about the origin of the fire.After repeated requests for product return and additional information, the patient¿s representative has not provided additional information at this time and has not indicated if additional information or the product will be returned.If additional information and/or the product becomes available, the complaint and investigation will be reopened.The device history records were reviewed and the records revealed that the universal battery charger (ubc) was manufactured in accordance with manufacturing and quality assurance (qa) specifications.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) (rev.C) contains the following information for safety testing and classification: the heartmate iii left ventricular assist system has been thoroughly tested and classified by underwriters laboratories, llc (ul) to the fire, casualty, and electric shock hazard requirements of the following safety standards, as applicable: ¿ iec 60601-1:2012 (ed.3.1) ¿ iec 60601-1:2005 + corr.1:2006 + corr.2:2007 (ed.3.0) ¿ iec 60601-1-11:2015 ¿ iec 60601-1-8:2006 + a1:2012 ¿ iec 60601-1-6:2010 + a1:2013 ¿ iec 62366:2007 + a1:2014 ¿ en 60601-1:2006/a1:2013 (ed.3.1) ¿ en 60601-1:2006 +corr.2:2010 (ed.3.0) ¿ ansi/aami es60601-1:2005/(r)2012 and a1:2012, c1:2009/(r)2012 + a2:2010/(r)2012 (ed.3.1) ¿ ansi/aami es60601-1:2005/(r)2012 and c1:2009/(r)2012 and a2:2010/(r)2012 (ed.3.0) ¿ can/csa c22.2 no.60601-1:14 (ed.3.1) ¿ can/csa c22.2 no.60601-1:08 (ed.3.0) ¿ can/csa c22.2 no.60601-1-11:15 these standards require making the following declarations and stating the type and degree of protection for listed hazards.¿ ul 60601-1, 1st ed., 2006-04-26 ¿ can/csa-c22.2 no.601.1-m90 (r2005) the heartmate universal battery charger instructions for use (ifu) (rev.D) instructs users to not use a damaged ubc, and to obtain a replacement if necessary.The user is also warned to refer all service and maintenance of the ubc to authorized and trained personnel.Section 6.0 ¿routine inspection and cleaning¿ within the ifu instructs users to check the ubc for signs of damage at least once per week.The heartmate 3 patient handbook (rev.G, section 3 ¿ ¿powering the system¿) instructs users to keep the ubc dry and away from water or liquid.This section also warns the user that if the ubc comes in contact with liquid, it may fail to operate properly or cause an electrical shock.The heartmate 3 patient handbook (rev.G) cautions the user 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.

• Brand Name: HEARTMATE UNIVERSAL BATTERY CHARGER
• 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: 17221255
• MDR Text Key: 318051528
• Report Number: 2916596-2023-03980
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 00813024010678
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1440
• Device Catalogue Number: 1440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: White