Model Number 3CX*FX25RWC |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2022 |
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.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they have noticed a black piece of defoamer material.Per facility, as the circuit was recirculating the perfusionist noticed a black piece of what looks like defoamer material.They tore down circuit and rebuilt pump.No patient involvement.There was 10 minute delay in the procedure.The product was changed out.The surgery was 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 may 6, 2022.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.
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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) 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 upon evaluation of the provided photo, the foreign material was confirmed in the reservoir housing.It is likely that the foreign material is part of the defoamer that is inside of the cr filter; however, without the actual piece of foreign material, it is unable to be tested and measured for confirmation.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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