Model Number 3CX*FX25RWC |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2023 |
Event Type
malfunction
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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.For this reason, terumo references evaluation conclusion code 11.H6: component code: 934 - reservoir.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code #1: 1069 - break.Medical device problem code #2: 1135 - crack.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, they noticed a damaged reservoir.As per the salea associate, the top of reservoir at the base of the venous inlet was cracked, in a way that looks as if it was dropped and landed on the venous inlet.No patient involvement.Product was changed out.Procedure completed successfully.
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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 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 10,11, 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.The returned sample was inspected upon receipt and confirmed to have significant damage to the reservoir lid.A representative retention sample was visually inspected, no damage noted on the device.All capiox units are 100% visually inspected at several points in the production and packaging processes.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Event Description
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Damaged reservoir.
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Event Description
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Damaged reservoir.
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Manufacturer Narrative
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His 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 may 5, 2023.Upon further investigation of the reported event, the following information is new and/or changed: 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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Search Alerts/Recalls
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