Model Number 3CX*FX15RW40C |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2021 |
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 non clinical activity, they found 3cx*fx15rw40c was mixed with big box of 3cx*fx25rec.No patient involvement.
|
|
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 3, 2021.Upon further investigation of the reported event, the following information is new and/or changed: b3: (date of event).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: h6 (identification of evaluation codes 3331, 4114, 3221, 4315).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned and pictures were not provided so a thorough investigation could not be conducted.The labels and serial number counts are correct for affected lot numbers.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: 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: 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).H6 (identification of evaluation codes 10, 4245, 4308).Type of investigation: #: 10 - testing of actual/suspected device.Investigation finding #: 4245 - packaging contains incorrect device.Investigation conclusions: 4308 - cause traced to transport/storage.The affected sample was inspected upon receipt to show a fx25 inside of a fx15 box.It is unknown exactly when or how this event occurred.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
|
Search Alerts/Recalls
|
|