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

Model Number 1440

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

Age of device: five years, 18 days.The patient remains on lvad support with no further issues reported.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with left ventricular assist device (lvad) on (b)(6) 2013.It was reported that battery charger was not functioning properly; it began to spark and smoke when plugged in.Batteries were red in all 4 chargers with a ¿telephone¿ symbol.When plugged in at hospital, it began to spark and smoke.Batteries were changed and cleaned but the issue with charger persisted.A loaner charger was issued.Patient was asymptomatic.The defective charger will not be returning for evaluation.It was disposed.No further information was provided.

Manufacturer Narrative

Investigation summary: the reported event, of a damaged heartmate charger ¿ not working, was inconclusive (not determined).The customer also reported that the charger was sparking and smoking in one occasion.The customer discarded the unit.No product was returned for evaluation or repair.The customer replaced the damaged heartmate charger with a rental/loaner unit.Patient remains ongoing on the pump.No further information was provided.The manufacturer is closing the file on the event.

Manufacturer Narrative

Investigation summary: the reported event, of a damaged heartmate charger ¿ not working, was inconclusive (not determined).The customer also reported that the charger was sparking and smoking in one occasion.The customer discarded the unit.No product was returned for evaluation or repair.The customer replaced the damaged heartmate charger with a rental/loaner unit.Patient remains ongoing on the pump.No further information was provided.The manufacturer is closing the file on the event.

Manufacturer Narrative

Age of device was inadvertently reported incorrectly.Since the device was manufactured on 1 aug 2013, the approximate age of the device is 5 years.

Manufacturer Narrative

Section a was updated with the correct patient information.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE UNIVERSAL BATTERY CHARGER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7780817
• MDR Text Key: 117282110
• Report Number: 2916596-2018-03317
• 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: 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,Followup,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 93 KG