MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS STERILE FX15RE OXY W. 4L RESERVOIR; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE40

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 12/11/2015

Event Type  Injury  

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 information becomes available.(b)(4).Conclusions: conclusion not yet available - evaluation in progress.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass the oxygenator clotted.The oxygenator and approximately one foot of 3/8in tubing was cut out during surgery.Both were filled with blood.Unknown amount of blood loss.Terumo is conservatively reporting as a serious injury because the amount of blood loss is unknown.According to terumo, blood loss of greater than 100cc is considered a serious injury.Product was changed out.Surgery was completed successfully with delay.

• Brand Name: STERILE FX15RE OXY W. 4L RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5323952
• MDR Text Key: 34267523
• Report Number: 1124841-2015-00342
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 3CX*FX15RE40
• Device Lot Number: TM19
• Other Device ID Number: (01)00699753450455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2015
• 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
• Patient Outcome(s): Other