MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX25RECA

Device Problem High Readings (2459)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

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.For this reason, terumo references evaluation conclusion code 11.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the potassium levels shot up to over 7.3.It is unknown if the product malfunction cause or contribute to an injury.Terumo continues to attempt to gain more information regarding this event from the user facility.As per user facility, "ccp went on bypass and potassium levels shot up to over 7.3.Before bypass potassium levels were at 4.3.After bypass potassium levels went back down to 4.0.Ccp's thought maybe there was an increase in potassium levels because of a water leak in the oxy.There was no noticeable increase in volume in the reservoir during bypass and post bypass there was no known increase in hemolysis after.Ccp's would like our lab to check and see if there was a leak in the heat exchanger.*product was not changed out.*procedure 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 september 8, 2022.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H6 (adverse event problem 2199, 4582, 11).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received.The product did not malfunction cause or contribute to an injury.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 213, 67) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 67 - no problem detected the returned sample was found to have no visual anomalies upon receipt.After being rinsed and dried, the heat exchanger of the sample was filled with colored water, the water outlet port was blocked, and air pressure of 3kgf/cm2 was applied to the water channel form the water inlet port, with no leakage observed.The blood channel was then filled with colored saline solution, the blood outlet port was blocked and air pressure of 2kgf/cm2 was applied to the blood channel from the blood inlet port.No leakage was observed.The evaluation of the returned sample was found to have no anomalies leading to leakage after cleaning.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15378988
• MDR Text Key: 306003986
• Report Number: 1124841-2022-00150
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: 2G20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1