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

Catalog Number 397002-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Hemolysis (1886)

Event Date 01/05/2018

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 certified hospital, reported that the patient was supported by the companion 2 driver for less than 24 hours and developed hemolysis.The customer also reported the patient was subsequently switched to the backup companion 2 driver and the patient was "better" after.The customer also reported that it was unclear if the issue was related to the driver or patient conditions.

Manufacturer Narrative

The customer-reported patient hemolysis (ldh around 2000) caused by a possible device malfunction was unable to be confirmed or reproduced during investigation testing.A device malfunction could not be reproduced during investigation testing using the patient simulator because the dmc tank contains water, not blood.The driver passed all functional testing and was subjected to an additional 70 -hour observation run in an attempt to observe a possible malfunction or change in driver performance.The driver performed as intended, and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

Manufacturer Narrative

Corrected data section h1 ce 4131 follow-up report 2.

• 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: 7229337
• MDR Text Key: 98629595
• Report Number: 3003761017-2018-00034
• 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: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

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: 01/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 01/12/2018; 01/12/2018
• Supplement Dates FDA Received: 07/19/2018; 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR