MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION DRIVELINES

Catalog Number 193002-001

Device Problems Misconnection (1399); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion drivelines were not supporting a patient.The companion drivelines will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The companion drivelines were not supporting a patient.The customer, a syncardia certified hospital, reported that the companion drivelines left and right cpc connectors were switched.

Manufacturer Narrative

The companion drivelines were not returned to syncardia for evaluation.The customer-reported issue of incorrectly positioned cpc connectors on the companion drivelines was confirmed through review of the customer-provided image.The drivelines were not returned and therefore could not be functionally evaluated or examined.This malfunction is an isolated incidence of human error in the assembly and inspection processes at the supplier.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.(b)(4) follow-up report 1.

Event Description

The companion drivelines were not supporting a patient.The customer, a syncardia certified hospital, reported that the companion drivelines left and right cpc connectors were switched.

• Brand Name: SYNCARDIA COMPANION DRIVELINES
• Type of Device: COMPANION DRIVELINES
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6855037
• MDR Text Key: 86620290
• Report Number: 3003761017-2017-00169
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 193002-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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