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

Model Number	3CX*RX25RE
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has received the 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 when more information becomes available.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular, prior to cardiovascular bypass, during out of box,holes were noticed on the box upon received.Per user facility, a forklift hit the boxes during delivery.No patient involvement.
Additional 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 2, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 111, 4308) method code #1: 10 - testing of actual/suspected device method code #2: 3331 - analysis of production records results code: 111 - packaging problem identified conclusions code: 4308 - cause traced to transport/storage the sample was visually inspected and noted that there was a hole to the side of the outer boxes.The internal packaging was inspected and found the damage to the outer boxes caused holes in the inner boxes.Retention samples are not kept of the four pack shipping container.All capiox units are 100% visually inspected during and after packaging.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9777020
• Report Number: 1124841-2020-00052
• Device Sequence Number: 2411510
• Product Code: DTZ
• UDI-Device Identifier: 00699753450103
• UDI-Public: (01)00699753450103
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: XN18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1