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

Catalog Number 397002-001

Device Problems Filling Problem (1233); Device Displays Incorrect Message (2591)

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

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited high fill volumes while in patient use at the hospital (b)(6).The customer also reported the high fill volumes were at 70ml for a cardiac frequency for 120 beats per minute (bpm), whereas the patient's previous drivers displayed fill volumes at 50ml for 120 bpm.The customer also reported that the patient was switched to backup driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited high fill volumes, it did not prevent the driver from performing 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.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited high fill volumes while in patient use at the hospital (b)(6).The customer also reported the high fill volumes were at 70ml for a cardiac frequency for 120 beats per minute (bpm), whereas the patient's previous drivers displayed fill volumes at 50ml for 120 bpm.The customer also reported that the patient was switched to backup driver.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no anomalies.The patient file was copied and reviewed, which revealed multiple left fill volume high alarms and a discrepancy of 11 cc between the left and right fill volumes.During investigation testing, the high fill volume alarms were not observed.The discrepancy between the left and right fill volumes, however, was reproduced.The root cause was a malfunction of the right mass flow sensor cable.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited high fill volumes, mass flow sensors are used for monitoring purposes and do not impact the life-sustaining functions of the driver.The mass flow sensor cables were replaced and the companion 2 driver was serviced and passed all functional and performance testing before being placed into finished goods.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.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5154717
• MDR Text Key: 28750136
• Report Number: 3003761017-2015-00358
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 10/13/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2011
• 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: 50 YR