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

Catalog Number 397002-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemolysis (1886)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer, a syncardia authorized distributor, reported that the patient developed hemolysis a few days after tah-t implant while supported by the companion 2 driver.The customer also reported that while the companion 2 driver was connected to wall air, the internal compressor of the driver would cycle on and off.The customer also reported that when the hemolysis did not improve, the patient was switched to the backup companion 2 driver (mfr.Report #: 3003761017-2018-00007).

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.The customer-reported development of patient hemolysis caused by a possible device malfunction was unable to be confirmed or reproduced during investigation testing.The driver passed all functional testing and was subjected to an additional 48-hour observation run to observe any possible change in performance.The driver performed as intended.The customer-reported internal compressor cycling was reproduced and the root cause was determined to be a malfunction of the manual pressure regulator.The compressor cycling has no clinical impact on the ability of the driver to sustain its life-supporting functions.Syncardia has a corrective and preventive action (capa) for this issue of compressor cycling.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia authorized distributor, reported that the patient developed hemolysis a few days after tah-t implant while supported by the companion 2 driver.The customer also reported that while the companion 2 driver was connected to wall air, the internal compressor of the driver would cycle on and off.The customer also reported that when the hemolysis did not improve, the patient was switched to the first backup companion 2 driver and the hemolysis continued (mfr.Report #: 3003761017-2018-00007).The customer also reported that the patient was then switched to the second backup companion 2 driver and the patient conditions improved.

• 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: 7219318
• MDR Text Key: 98250762
• Report Number: 3003761017-2018-00006
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 0085800003107
• UDI-Public: (01)0085800003107
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR