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

Catalog Number 397002-001

Device Problems False Alarm (1013); Noise, Audible (3273)

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

Event Date 09/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that on (b)(6), 2015, the companion 2 driver exhibited an incorrect left pressure alarm while supporting a patient at the (b)(6).The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient 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 evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that on (b)(6) 2015, the companion 2 driver exhibited an "incorrect left pressure" alarm while supporting a patient at (b)(6).The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.Companion 2 driver s/n (b)(4) was returned to syncardia for evaluation.The patient file was copied and reviewed, which confirmed the "left pressure incorrect" alarms as reported by the customer.During failure investigation testing, a malfunction of the left electronic pressure regulator was found to be the root cause of the customer reported issue.The left electronic pressure regulator was replaced, the driver was serviced, and passed all final performance testing.Despite the customer reported "left pressure incorrect" alarms, risk to the patient was low because the companion 2 driver continued to perform its life-sustaining functions.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: 5084312
• MDR Text Key: 26496393
• Report Number: 3003761017-2015-00294
• 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
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• 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: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2015
• 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: 55 YR