MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RW OX W / RES; BLOOD GAS OXYGENATOR

Model Number 3CX FX25RW

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 04/17/2015

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass the tubing attached to the reservoir of the fx25 oxygenator became disconnected.The user reconnected the tubing to the reservoir and continued with the case.Blood loss of approx 100cc.Product was not changed out.Surgery was completed successfully.Terumo considers a blood loss of 100cc or more in an adult case to be a serious injury.

Manufacturer Narrative

Terumo has not received the actual device for eval; therefore, the investigation has yet to be completed.Terumo plans on submitting a f/u report when the investigation is complete and more info becomes available.(b)(4).

Manufacturer Narrative

A second follow-up will be submitted upon completion of the investigation and/or submission of new information.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25RW OX 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, quality mgr ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4761831
• MDR Text Key: 5775791
• Report Number: 1124841-2015-00144
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 3CX FX25RW
• Device Lot Number: RM06
• Other Device ID Number: (01) 00699753450479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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): Other