Model Number 3ZZ*FX25RWCA |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2022 |
Event Type
malfunction
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the pigtail of the oxygenator was broken.No patient involvement.Product was changed out.Procedure was completed successfully.
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Manufacturer Narrative
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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).
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Manufacturer Narrative
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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 february 24, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer), g2 (report source - added health professional and user facility), 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.
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Manufacturer Narrative
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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 expiration date).G2 (report source - health professional and user facility).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, 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 finding: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was inspected upon receipt to confirm a damaged arterial pigtail.A representative retention sample was reviewed for damage to the unit, specifically in the area of the arterial sampling pigtail.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.
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Search Alerts/Recalls
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