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

Model Number 397002-001

Device Problems Battery Problem (2885); Audible Prompt/Feedback Problem (4020)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia authorized distributor, reported that the companion 2 driver did not pass the system check.

Manufacturer Narrative

The customer-reported issue was confirmed by review of the patient data file.The system checkout logs revealed three system check test failures which reported a 9-volt battery reading below acceptable limits (6.500 v - 10.000 v).During investigation testing, the driver did not pass the system check for this same reason thus replicating the customer-reported issue.The 9-volt battery is replaced during servicing after 90 days of driver use or at the two-year service interval regardless of days of use.The 9-volt battery was replaced during the most recent service completed on 06 aug 2019.The 9-volt battery installed at the time of service had an expiration date of march 2021.The driver was shipped on 14 oct 2019 and was not returned for service prior to the battery's expiration date because the driver had not accumulated 90 days of patient support.It is suspected that the 9-volt battery experienced normal depletion below the specified 6.5 volts.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5507 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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11701327
• MDR Text Key: 246507620
• Report Number: 3003761017-2021-00046
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 06/02/2021
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2021
• 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