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

Model Number 397002-001

Device Problems Device Stops Intermittently (1599); Calibration Problem (2890)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the companion 2 driver compressor cycled on and off, the companion 2 driver continued to perform its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the companion 2 driver compressor cycled on and off while supporting a patient.The customer also reported that the patient was switched to a backup companion 2 driver which subsequently had an issue therefore the hospital staff switched the patient back onto the original companion 2 driver.The customer also reported that the patient was extremely stable and continues to be supported by the original companion 2 driver.

Manufacturer Narrative

The customer-reported compressor cycling on the companion 2 driver was confirmed via review of the driver's alarm history, and was reproduced during investigation testing.The root cause of the compressor cycling was determined to be a malfunction of the manual pressure regulator, which was unable to maintain the required pressure set point value.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.(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
• MDR Report Key: 7586804
• MDR Text Key: 111017923
• Report Number: 3003761017-2018-00228
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• 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: 06/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR