Model Number 3CX*FX25REC |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2021 |
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.
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a crack in manifolds was observed.No patient involvement.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.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 sample was inspected and confirmed a damage to the female l-shaped connector.A representative retention sample was reviewed for a previous complaint, with no damage to the unit observed, including the manifold.During the investigations of similar events, replication testing found that this crack appears on the part when the l connector is over tightened on a port.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 4, 2021.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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Search Alerts/Recalls
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