Model Number 3CX*FX25RWC |
Device Problem
Noise, Audible (3273)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/30/2021 |
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.(b)(4).
|
|
Event Description
|
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, they noticed there was a gurgling inside the oxygenating chamber.As reported, during the filling phase with a pump flow of 2.5 l/min with 2 liters of air and 40% of fio2 there was a gurgling inside the oxygenating chamber which led to the replacement of the device.No patient involvement.Product was 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 september 20, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h3 (device evaluation anticipated by manufacturer - 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.
|
|
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: d4 (additional device information - added exp date) g3 (date received by manufacturer) g6 (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, 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 sample was visually inspected upon receipt, no breakage or similar anomaly was noted that could lead to air entering.The sample after rinsed was filled with colored normal saline with the blood outlet port side locked, and then air pressure of 2kgf/cm2 was applied to check for any leakage.No leak was observed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
|
Search Alerts/Recalls
|
|