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

Model Number 1440

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Smoking (1585); Improper or Incorrect Procedure or Method (2017); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that a glass of water was spilled on the battery charger.The charger started smoking and stopped working.The patient was given a loaner and the charger would be sent in for repair.

Manufacturer Narrative

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

Event Description

Additional information: it was reported that the patient was stable and there was no adverse patient impact.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of fluid ingress issue was confirmed with the returned universal battery charger (serial # (b)(6).The submitted reference photo captured what appears to be remnants of fluid on the housing.Also, the reference photos captured corrosion damage on electrical components on the internal printed circuit board.Event details indicated a glass of water was inadvertently spilt on the unit and the damage is consistent with a fluid ingress issue.The customer declined repair and requested the unit to be scrapped.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.Universal battery charger (serial # (b)(6) was shipped to the customer on 04aug2020.Care and maintenance of the heartmate universal battery charger (ubc) are addressed in the heartmate ii instructions for use (rev c) and the heartmate 3 instructions for use (rev c).Section 3, power the system, description of battery charger pocket lights and their meaning.There are warnings that states ¿do not allow water to penetrate into the interior of the equipment.Do not immerse equipment in water or liquid.Immersion in water or liquid may cause the pump to stop.¿ under equipment storage and care, ¿cleaning the power module and mobile power unit¿ periodically, and as needed, unplug the power module and mobile power unit and clean the exterior surfaces using a clean, damp (not wet) cloth.You may use a mild detergent, if necessary.Keep the power module and mobile power unit dry and away from water or liquid.If the power module or mobile power unit comes into contact with water or liquid, it may fail to operate properly or you may get an electric shock.Do not clean the power module or mobile power unit while it is being used to power the left ventricular assist system.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: 14776188
• MDR Text Key: 299966860
• Report Number: 2916596-2022-11871
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• 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: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American