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

Model Number 3CX*FX15RW30C

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

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.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, they have received the wrong style of oxygenator from their bundle pack.They opened it up and found out it was a different type of oxygenator.They should have receive pn: 3cx*fx15rw30c instead they received: 3cx*fx15re30c ln: xh15 no patient involvement.

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 may 19, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h4 (device manufacture date) h6 (identification of evaluation codes 3331, 4114, 170, 25) type of investigation: #1: 3331 - analysis of production records type of investigation #2: 4114 - device not returned investigation findings: 170 - manufacturing process problem identified investigation conclusions: 25 - cause traced to manufacturing the affected sample was not returned for investigation.During review of the dhr for 3cx*fx15rw30c, ln xh15, it was found that three units from this lot were subjected to packaging damage rework.The serial numbers associated with this rework were found to be east oriented units, which were then placed in west labeled packaging.An internal investigation is in progress.Retention samples are not maintained for this product code.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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: 11848344
• MDR Text Key: 251457765
• Report Number: 1124841-2021-00118
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: XH15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1