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

Model Number	3CX*RX25RW
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The distributor reported to terumo cardiovascular that upon receipt of the shipment there were 48 pieces too few of the device as compared to the ship list.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.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 4114, 3331, 4246, 4308).Method code #1: 4114 device not returned.Method code #2: 3331 analysis of production records.Results code: 4246 transport/storage problem identified.Conclusions code: 4308 cause traced to transport/storage.The investigation verified that the order was inappropriately picked and shipped.It was determined that was a human error during the picking and shipping process.During that period areas were reinforced to catch up on back order that are experienced at the dc.The root cause was a human error at the distribution center during the picking and shipping process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8833840
• Report Number: 1124841-2019-00205
• Device Sequence Number: 2877036
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: 03/31/2022
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: XE22
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1