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

The actual sample was not returned for evaluation so a retention sample from the same lot was examined.Measurements were taken of the retention sample tubing barbs in addition to a retention sample's reservoir barbs.It revealed that each device was within specification and had the same barb diameter with no anomalies.Further, correspondence from the user facility revealed that tie bands were not used on the tubing to properly connect to the reservoir.Device labeling addresses the potential for such an occurrence in the instructions-for-use with statements such as, "push all tubing past the second barb and band all connections in the circuit." additional information provided by the user facility indicated that reservoir tubing from another manufacturer was used during the case; therefore, this complaint was not confirmed and is attributed to another device causing the event and use error.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: 4761813
• MDR Text Key: 5775793
• Report Number: 1124841-2015-00145
• 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,company rep
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• 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
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/21/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other