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

Model Number 74284

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 04/10/2018

Event Type  Injury  

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.For this reason, terumo references evaluation conclusion.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the gases dropped.There was 310 ml blood loss.Product was changed out.Procedure was completed successfully.The first pump run was 313 mins (~5 ¼ hours) then they were off bypass for 93 mins resulting in the oxygenator being exposed to blood for 406 mins (6 hours and 46 mins) prior to the second pump run.During the 93 minutes off pump the patient was given protamine, two vials of factor vii, 27 cell savers and lots of blood products.Only the manifold line was kept open to recirculate blood in the oxygenator during the 93 mins off cpb; the perfusionist had flushed through to the cell saver for the residual fluid to be ¿pink¿.There were low act values periodically throughout cpb, 418 at 0900, 443 at 0930, 386 at 0945, 406 at 1045, 408 at 1115, 445 at 1515.The lactate levels were very high throughout cpb, ranging from 4.6 ¿ 13.5.The ph values were very acidotic throughout cpb as well as large base deficits (-3.5 to -11.5).There was a significant amount of sodium bicarbonate administered (~fifteen 50 meq doses).At 1330 the surgeon was notified of the oxygenator status (po2 was 61 at that time) and the po2 increased to 112 then 120 after an increase in sweep gas to 10 lpm with venous saturations of 78 and 78 respectively.The oxygenator was changed out at 1450 (after the second cpb run) and there were no blood gas values charted from 1410 ¿ 1515 as they were off bypass from 1450 - 1514.

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 april 30, 2018.(b)(4).The returned sample was visually inspected.No obvious anomaly was found, such as a break, which would relate to the reported issue in the appearance.The sample was tested for its gas transfer performance.No anomalies were noted and the obtained values met factory specifications; therefore, a definitive root cause could not be determined.It is likely that the gases were hindered from being transferred sufficiently by some factors including clot formation, wet lung and plasma leak, resulting in the reported issue.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: 7474274
• MDR Text Key: 106952602
• Report Number: 1124841-2018-00071
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 74284
• Device Catalogue Number: N/A
• Device Lot Number: WA01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 81