MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX15REC W/3L RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX15RE30CA

Device Problem Break (1069)

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

Event Date 07/12/2021

Event Type  malfunction  

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

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the venous temperature probe broke.It is unknown if there was a delay in the procedure, and if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.As per the chief of perfusionist, on monday, (b)(6), he had an avr/cabg case and the small terumo pack that he was using had a broken venous temperature probe on the venous inlet of the reservoir.He hadn't noticed until he had already built and primed the pump, upon attaching all the safety devices and temperature probes, he noticed the white venous temperature probe connection seemed loose.He gave it a non-forceful wiggle and it just came right off.Air was leaking into the venous inlet from where the probe was, he had to replace the entire pump pack due to sterility concerns and the potential for air in the venous line.The product was changed out.

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 july 30, 2021.  upon further investigation of the reported event, the following information is new and/or changed: b5: (updated describe event or problem).G3: (date received by manufacturer).G6: (indication that this is a follow-up report).H2: (follow-up, due to additional information).H6: (adverse event problem 2645, 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

Additional information received, indicates that, there was no delay in the procedure.And the surgery was completed successfully with no patient effect.

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: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 11, 3331, 4114, 3259, 25).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was not returned.However, a review of ncrs showed broken venous thermistors found in production.Enhanced inspection was initiated relating to the insertion depth of the venous thermistor.A representative retention sample of the same lot number was reviewed for damage to the venous inlet on the reservoir with no damage observed on the sample.A change is currently in process to update procedures related to venous thermistor assembly and inspection.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX15REC W/3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 12252379
• MDR Text Key: 264279847
• Report Number: 1124841-2021-00183
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 3ZZ*FX15RE30CA
• Device Catalogue Number: N/A
• Device Lot Number: YM26
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1