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

Model Number 397002-001

Device Problems Output Problem (3005); No Apparent Adverse Event (3189)

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

Event Date 09/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver had a suspected cardiac output inaccuracy.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

The patient data file was reviewed and found that during support ((b)(6) 2020 - (b)(6) 2020) the cardiac output was stable and there were no alarms or malfunctions that would indicate a device malfunction.Because the complaint stated there was a large variance in cardiac output during use, the data for the last hour of support prior to driver switch was reviewed.Seven data points sampled during the alarm time were found to be within range of acceptability.Visual inspection of the external components found a small dent in the driver's touchscreen display.Damage is cosmetic and does not impact the driver's functionality.Visual inspection of internal components found no evidence of damage or abnormalities.The driver passed incoming functional testing and cardiac output was found to be stable during the testing.The customer complaint was not replicated.The complaint could not be confirmed or replicated.Patient data file review found no alarms or indications of a device malfunction.Data review found cardiac output and fill volumes were stable and met specifications during patient use.The driver passed incoming functional testing with no alarms observed.No evidence of a device malfunction was found.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.(b)(4) follow-up report 1.

• 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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10705485
• MDR Text Key: 212110059
• Report Number: 3003761017-2020-00209
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/26/2020
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2018
• 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: 52 YR
• Patient Sex: Male