Model Number 3CX*FX25REC |
Device Problem
Device Damaged Prior to Use (2284)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/22/2020 |
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 out of box, the product was concealed damaged.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 january 12, 2021. upon further investigation of the reported event, the following information is new and/or changed: 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 evaluatio.N codes 10, 11, 3331, 3259, 4307).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.Upon review of the complaint sample the arterial pigtail luer cap was found to be damaged.A representative retention sample from the same lot number was inspected and found to be free of damage.All capiox units are 100% visually inspected at several points in the production process.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 12, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 4747, 4582).Component codes: 4747 - packaging health effect - clinical code - 4582 - no clinical signs, symptoms or conditions.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|
|
Search Alerts/Recalls
|
|