MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T CANNULA; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problems Use of Device Problem (1670); Human Factors Issue (2948)

Patient Problem Loss of consciousness (2418)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

The customer was retrained by syncardia personnel to have the hospital staff perform a head to toe check after any event to ensure that all equipment is connected and functioning as intended.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) initial.

Event Description

The customer, a syncardia certified hospital, reported that while the patient was transitioned from the bed to a chair, the cpc connectors became disconnected from the tah-t cannulae and the patient collapsed.The customer also reported that the cpc connectors were immediately reconnected to the tah-t cannulae, but were incorrectly connected.There was no adverse patient impact and the connection was corrected the following morning.

• Brand Name: SYNCARDIA 70CC TAH-T CANNULA
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6110417
• MDR Text Key: 60247868
• Report Number: 3003761017-2016-00368
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 500101
• Device Lot Number: 100156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR