Model Number 3ZZ164275X |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2022 |
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.For this reason, terumo references evaluation conclusion code 11.(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 pump head leaked.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 november 4, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - updated lot number).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 exp 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, 4210, 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 #1: 4210 - leakage/seal investigation findings #2: 3259 - improper physical structure investigation conclusions: 4307 - cause traced to component failure the affected sample was inspected upon receipt with cracking noted along the top housing where it mates to the separator and was attached to a circuit and filled with water and pressurized to 750mmhg.It was noted that a slow leak was observed from where the top housing mates to the separator.A retention sample from the same product code/lot number combination was obtained.The sample was attached to a circuit and filled with water and pressurized to 750mmhg for approximately 20 minutes 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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