MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML; BLOOD GAS OXYGENATOR

Model Number 3CX*RX15RW30

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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 during cardiopulmonary bypass, specifically at the time of entry in partial extracorporary circulation, the patient saturation decreased, reaching 70%, noticed that the post oxygenated blood side's coloring was equal to the unsaturated venous return.The amount of blood loss is unknown.Product was changed out.Product 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 march 27, 2018.(b)(4).The actual sample was not returned for evaluation.Retention samples were obtained from products of the same rx15 size as the actual sample that used the same fiber lot numbers.Gas transfer testing was performed on the retention units and were found to meet factory specifications.Review of the device history record confirmed there was no indication of production related anomaly or nonconforming inspection results.Without the actual sample, a definitive root cause can not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: HOLLOW FIBER OXY WITH 3000 ML
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7376246
• MDR Text Key: 103651354
• Report Number: 1124841-2018-00053
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 3CX*RX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: TP14
• Other Device ID Number: (01)00699753450127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 27