MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II-SYSTEM MONITOR; VENTRICULAR (ASSISST) BYPASS

Model Number 1286A

Device Problems Fluid/Blood Leak (1250); Smoking (1585)

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

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - 18 years, 7 months.Investigation conclusion: the reported event of a defective system monitor as well as a broken front frame was confirmed and reproduced via evaluation of the returned system monitor (serial number: (b)(4)).Visual observation of the returned system monitor revealed that the lcd screen was discolored, and the upper right-hand and the lower left-hand corners were both damaged.The returned system monitor, serial number (b)(4), was evaluated under work order# (b)(4) and the reported event was confirmed.Troubleshot the system monitor revealed a defective main pcb.The device was forwarded to ppe group for additional analysis.The returned device was evaluated by connecting the unit to a power module.The green led on the system monitor lit up, however, the unit was not functioning as expected; a burned odor was noted.To determine the source of the problem, the unit was disassembled to inspect the internal components.Visual analysis performed on the main pcb revealed several damaged components.Further inspection revealed a green residue/corrosion seen under the lcd as well as the internal housing.As parts were unavailable, the device was scrapped.The corrosion appears to be caused as a result of a fluid ingress, a root cause for the observed fluid ingress was unable to be identified through this analysis.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the system monitor would not power on and had a broken front frame.It was returned for repair.No patient was involved for the event.

Manufacturer Narrative

Brand name: correction.

• Brand Name: HEARTMATE II-SYSTEM MONITOR
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8574621
• MDR Text Key: 143872616
• Report Number: 2916596-2019-02172
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1286A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1