Model Number 3CX*FX25RWC |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Terumo has received the device for evaluation; however, 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.Component code: 4761 - access port; health effect - impact code: 2645 - no patient involvement; health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1069 - break; 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, the thermistor port broke off.The thermistor port was in the inlet port of the reservoir.Additionally, the perfusionist was setting the oxygenator up for a future use; upon putting the thermistor probe, it broke off.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¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on february 28, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration 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 the venous temp probe was broken off the port.A representative retention sample was inspected for damage with no damage noted on the device.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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