Model Number 3ZZ164275X |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/22/2020 |
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, the centrifugal head leaked.No patient involvement.Product was changed out.Procedure 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 august 26, 2020. upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability - added date returned to manufacturer); g4 (date received by manufacturer); g7 (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 exp date); g4 (date received by manufacturer); g7 (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, 4210, 4307).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 4210 - leakage/seal.Conclusions code: 4307 - cause traced to component failure.Two samples were returned and inspected upon receipt with no visual anomalies noted.The samples were then setup to pressurize.One unit had leakage observed from two places where the top housing mates to the separator.The second unit did not have obvious leaks.The second unit was setup in a circuit with colored water (to aid in visibility) where leakage was observed at one place where the top housing mates to the separator.A representative retention sample was pressurized to 1500mmhg for approximately 2 hours with no leakage observed.Production records were reviewed and were found to have no significant anomalies associated with leakage or the equipment for assembling the pump housing.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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