MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RE W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*X25RE

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corporation that during setup, it was found that the oxygenator was dislodged from the connector and hanging on one side.The customer attempted to reconnect it but was unsuccessful.The device was changed out, and the procedure was completed successfully without delay.No pt involvement as this occurred during setup.Product was changed out.Surgery was completed successfully without delay.

Manufacturer Narrative

Terumo has received the actual 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 more info becomes available.For this reason, terumo referenced evaluation conclusion code.(b)(4).

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular system in the initial report submitted to the fda on july 21, 2015.(b)(4).Upon completion of the investigation, the event was confirmed.The actual sample was visually inspected upon receipt and it was found that oxygenator subassembly was disconnected from the reservoir.No components were broken and minimal damage was observed on the connecting ring.One side of the neck was disconnected from the oxygenator lug.No other damage was observed.In an attempt to recreate the reported damage, a completed oxygenator/reservoir unit was dropped from approximately 4 feet onto the flat (venous) side of the reservoir.This resulted in the connecting ring disconnecting and on one side of the neck disconnecting from the oxygenator lug.A retention sample from the same lot was inspected and no anomalies were found.A review of the device history record also revealed no anomalies.The root cause was determined to be exposure to shock force while not in the original packaging.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25RE W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4934773
• MDR Text Key: 6437098
• Report Number: 1124841-2015-00213
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 3CX*X25RE
• Device Lot Number: TD30
• Other Device ID Number: (01) 00699753450462
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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