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

Model Number 397002-001

Device Problems Device Displays Incorrect Message (2591); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited a system malfunction alarm, it continued to perform its life-sustaining functions.The companion 2 driver will be 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 companion 2 driver exhibited a system malfunction alarm while supporting a patient.The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.

Manufacturer Narrative

The occurrence of a system malfunction alarm as reported by the customer was confirmed through a review of the patient file.Attempts to reproduce the system malfunction alarm through normal driver operation were unsuccessful; however, investigational testing of the key switch proved that a system malfunction alarm can be recorded if the key switch is improperly or incompletely turned.It is likely that the key switch was bumped or improperly turned all the way, causing the system malfunction alarm.The likely root cause of the customer-reported alarm was improper use, as testing indicated that the key was most likely left in the key switch during patient support.The driver passed all functional testing and was subjected to an additional 24-hour observation run in an attempt to observe a possible malfunction, change in performance, or occurrence of a system malfunction alarm.The driver performed as intended, no alarms sounded and there was no evidence of a device malfunction.Hospitals are instructed to remove the key from the driver during patient support.The syncardia companion 2 driver system operator manual (c2-900005) section 6.3 states: "when the driver is on, the key must be removed from the driver to prevent unintended interruptions to driver operation.Once removed, the key may be stored in a location determined by the clinical staff." section 12.9 and section 15.2.5 of the operator manual also state: "remove the key from the key switch when the driver is in operation.The key cannot be removed when the driver is switched off" and "remove the key from the key switch when the driver is in operation.The key cannot be removed when the driver is switched off", respectively.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.

• 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: 6884696
• MDR Text Key: 87857266
• Report Number: 3003761017-2017-00187
• 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: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

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: 10/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR