MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2019

Event Type  malfunction  

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 pre cardiopulmonary bypass, there were specks seen on the reservoir.As per user facility, the marks were difficult to see or differentiate from patient blood coming back through.No known consequences or impact to patient.The product was not changed out.The procedure 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 october 2, 2019.Upon further investigation of the reported event, the following information is new and/or changed: a3 (updated patient information - patient sex).B5 (describe event or problem - occur during priming).D4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H4 (device manufacture date).H6 (identification of evaluation codes (11, 4114, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 4114 - device not returned.Method code #3: 3331 - analysis of production records.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned for evaluation.Pictures provided with the complaint confirmed the existence of the specks.A representative retention sample was reviewed and there was no contamination within the device.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information indicate that the issue occur during priming.

• Brand Name: STERILE FX15RWC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9144850
• MDR Text Key: 162528865
• Report Number: 1124841-2019-00272
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: XH29
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1