MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR WEST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RW

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2020

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 prior to cardiopulmonary bypass, during a non clinical activity; the outer box tape of an oxygenator unit was noted to have a double layer of tape, making the user feel that the original seal was broken.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 september 25, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 111, 4307).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 111 - packaging problem identified.Conclusions code: 4307 - cause traced to component failure.The sample was not returned for investigation.However, the evaluation of the photo shows that, the first piece of tape does not contact the corrugated cutout per procedure and a second piece of tape placed overtop does.Retention sample was found to have only one piece of tape and that it contacted the corrugated cutout.Tape placement is 100% inspected in manufacturing.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10588177
• MDR Text Key: 208594686
• Report Number: 1124841-2020-00225
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (y/n): N
• PMA/PMN Number: K153213
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: XM14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1