Model Number 500101-001 |
Device Problems
Malposition of Device (2616); Connection Problem (2900)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/02/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The cpc connector has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
|
|
Event Description
|
The customer, a syncardia certified hospital, reported that the spring in the cpc connector of the cannula was displaced.The customer also reported that the cpc connector was replaced at the hospital and there was no clinical impact on the patient.
|
|
Event Description
|
The cpc (colder products company) connector is a component that provides the interface between the tah-t cannula and the drivelines.The customer, a syncardia certified hospital, reported that the spring in the cpc connector of the cannula was displaced.The customer also reported that the cpc connector was replaced at the hospital and there was no clinical impact on the patient.
|
|
Manufacturer Narrative
|
The cpc connector was returned to syncardia for evaluation.Visual inspection confirmed the customer-reported issue as the spring inside the female cpc connector was displaced and sitting sideways inside the housing.Although a definitive root cause for the spring displacement could not be determined, it is possible that a cpc connector spring can be displaced when the wire tie is threaded through, or removed from, the connector during or after a driver switch.Syncardia has a corrective and preventive action (capa) to address this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
|
|
Search Alerts/Recalls
|