MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 397002-001

Device Problem Computer Software Problem (1112)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited computer malfunction alarm.There was no reported adverse patient impact.The customer also reported the patient was subsequently switched to a backup driver and the original driver was tested and passed the system check the next day.

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited computer malfunction alarm.There was no reported adverse patient impact.The customer also reported the patient was subsequently switched to a backup driver and the original driver was tested and passed the system check the next day.

Manufacturer Narrative

Device history record (dhr) review confirmed that companion 2 driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found two computer malfunction alarms.Visual inspection of external and internal components found no abnormalities.Driver failed functional testing for acceptance at incoming inspection due to exhibiting a computer malfunction alarm immediately upon start up.Additional testing included power cycling driver while on bench and cover opened.Driver started up without alarm or malfunction, however, if digital i/o cable was moved or adjusted an alarm was triggered.Incoming inspection was re-initiated with a known functional replacement digital i/o cable.Driver passed all areas of functional testing without issue or alarm.A 48-hour observation run was performed with no malfunctions or alarms.A new digital i/o cable from inventory was placed on driver and device passed all areas of functional testing for acceptance.Failure investigation for this complaint confirmed the reported issue from data file review.The customer complaint was replicated during testing; root cause of the reported computer malfunction alarm was determined to be due to a faulty digital i/o cable.Failure investigation identified no test failures or damage that could have contributed to the complaint.Patient was switched to a backup driver without any reported adverse impact.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: donald webber ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12433825
• MDR Text Key: 270145901
• Report Number: 3003761017-2021-00178
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2018
• 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 Age: 27 YR
• Patient Sex: Female