MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE II LVAD DEVICE; VENTRICULAR (ASSIST) BYPASS

Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 12/06/2021

Event Type  No Answer Provided  

Event Description

(lvad) coordinator received a phone call from the patient stating that he was having multiple low flow alarms as well as low speed limit advisory alarms.The patient states that these alarms have been happening, although this was the first time that we heard of them.He claims that these alarms happen on battery as well as the pm.Concern for phase to phase so we brought him into the inpatient vad office to interrogate and send off log files to abbott as well as to get an x-ray of the drive line to see if we could pinpoint the area of damage.The interrogation of the lvad revealed that the patient had copious amounts of low flow alarms as well as low speed advisory alarms.The interrogation also revealed that the patient has had 9 pump stop alarms.Unfortunately, the log files as well as the x-rays indicate that he in fact does have a short to shield.This was confirmed by abbott.A drive line splice needed to be done in order to abate the alarms and decrease the risk of the pump stopping.Abbott engineers came to do this.Two engineers arrived and prepared the driveline for planned repair.Plumbers tape was placed over the silicone shielding and is to remain in place for 3 days.The patient was also sent home on an ungrounded cable.He was discharged feeling well.There were no alarms noted during the repair.Vad numbers remained consistent throughout the procedure.

• Brand Name: HEARTMATE II LVAD DEVICE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORP.; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 13691826
• MDR Text Key: 286750945
• Report Number: 13691826
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1