MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER

Catalog Number 397002-001

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

The customer reported that the companion 2 driver exhibited a "high temperature" alarm while supporting a pt at (b)(6).The pt was subsequently switched to the backup companion 2 driver.There was no reported adverse pt impact.The alleged failure mode poses a low risk to the pt because it did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

Efforts to reproduce the "high internal temperature" alarm during failure investigation testing were not successful.The driver passed all performance test requirements with no alarms and no anomalies.The driver performed as intended and there was no evidence of a device malfunction.Despite the customer-reported "high internal temperature" alarm, there was no adverse patient impact and the cardiac output remained within the acceptable range of 5 to 8 liters per minute (lpm).This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

Event Description

The companion 2 driver was returned to syncardia for evaluation.A visual inspection of the internal components revealed no anomalies.A review of the driver's electronic patient file revealed that no "high internal temperature" alarms recorded.The customer-reported issued could not be verified.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp, ra ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4812374
• MDR Text Key: 5924918
• Report Number: 3003761017-2015-00169
• Device Sequence Number: 1
• Product Code: LOZ
• 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,Health Professional,User Facility,Distributor,distributor,forei
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

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 Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Age: 51 YR