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

Catalog Number 397002-001

Device Problems Disconnection (1171); Device Handling Problem (3265)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 09/08/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that on (b)(6) 2015, the patient was found deceased in his assisted-living facility apartment with the companion drivelines disconnected from the companion 2 driver in his hand.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).Follow-up report 1.

Event Description

The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: companion 2 driver s/n (b)(4) (mfr report # 3003761017-2015-00291) and companion 2 driver s/n (b)(4) (mfr report # 3003761017-2015-00382).The customer reported that on september (b)(6) 2015, the patient was found deceased in his assisted-living facility apartment with the companion drivelines disconnected from the companion 2 driver in his hand.The customer reported that two companion 2 drivers, s/n (b)(4), were assigned to the patient at the time of the customer reported event.The customer reported that companion 2 driver s/n (b)(4) was in use at the time of the reported event.The patient file was copied and reviewed.Analysis of the data determined that driver s/n (b)(4) was not supporting the patient, driver s/n (b)(4) was the backup driver and not the primary driver as reported by the customer.Driver s/n (b)(4) was the primary driver at the time of the customer reported event.This was determined by comparing the cardiac data / alarm history from the drivers that were assigned to the patient at the time of the customer reported event.Visual inspection of the driver's "as received" condition revealed no anomalies.The driver in "as received" condition passed all required functional and performance testing and functioned as intended including the proper annunciation of audible alarms and presentation of visual indicators.Based on the investigation results and review of the electronic patient file at the time of the customer reported issue, the driver functioned as intended, and there was no evidence of a device malfunction.The companion 2 driver s/n (b)(4) was serviced and met all functional and performance testing before being released to finished goods.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 (Section G): 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: 5082779
• MDR Text Key: 25988604
• Report Number: 3003761017-2015-00291
• 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
• Type of Report: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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 Outcome(s): Death
• Patient Age: 51 YR