MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION PRESCRIPTIVE OXY PACK - CAPIOX; BLOOD GAS OXYGENATOR

Model Number 74281

Device Problem Use of Device Problem (1670)

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

Event Date 01/23/2019

Event Type  malfunction  

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 Description

The user facility reported to terumo cardiovascular that while warming from cardiopulmonary bypass, the po2¿s dropped to around 70.No known impact or consequence to patient.Product was not changed out.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 february 14, 2019.Upon further investigation of the reported event, the following information is new and/or changed: 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 additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected and no obvious anomaly was found such as break in the appearance.The actual sample having been rinsed and dried was tested for its o2 transfer volume and co2 removal volume.Bovine blood was circulated in the oxygenator module.No anomalies were revealed in the gas transfer performance of the sample with the obtained values meeting the factory specifications.Review of history records of the involved product lot number combination confirmed there was no indication of production related anomaly.The investigation result verified that the actual sample was the normal product with no issue in the gas transfer performance.With the involved pump record or detailed information about the event leading up to the reported event not available, the definitive cause cannot be determined from the available information.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: PRESCRIPTIVE OXY PACK - CAPIOX
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 8340861
• MDR Text Key: 139186269
• Report Number: 1124841-2019-00044
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• 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: 03/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 74281
• Device Catalogue Number: N/A
• Device Lot Number: WM29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1