MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SX OXYGENATOR W/ HR X COATING; BLOOD GAS OXYGENATOR

Model Number 3CXSX25RX

Device Problem Blocked Connection (2888)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a blocked manifold was observed.No patient involvement as this occurred during prime.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on april 19, 2018.(b)(4).The returned sample was visually inspected.It was discovered that the red stopcock handle on the returned sample had popped out of its snap-fit connection within the manifold.The returned sample was also manually flowed through as received and flow was blocked at the red stopcock location.After seating the stopcock handle appropriately, a manual flow test was attempted and completed successfully.A retention sample from the same product code and lot number was inspected and confirmed to not have mis-seated stopcock handles.All sampling manifolds are leak tested during manufacturing and visually inspected; therefore, it is likely that the unit was exposed to a shock force after manufacturing that caused the stopcock snap-fit to disengage.It was not able to be determined how or when the damage occurred.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SX OXYGENATOR W/ HR X COATING
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7442534
• MDR Text Key: 106265647
• Report Number: 1124841-2018-00065
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K153140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 3CXSX25RX
• Device Catalogue Number: N/A
• Device Lot Number: UM31
• Other Device ID Number: (01)00699753450097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1