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 11/22/2021 |
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, noticed foreign matter contamination floating in the reservoir after being primed using the pre-bypass filter.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.
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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 december 9, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date); 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.) ; h4 (added device manufacturer date).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, 4238, 25).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: 4238 - contamination of environment by device.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt to confirm a black substance that had been removed from the reservoir and encased in a piece of tubing.The substance was removed where it was found to be a piece of the defoamer found on the venous side of the reservoir.A representative retention sample was inspected to show no anomalies with the defoamer in the reservoir.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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