Model Number 3CX*RX15RE30 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/30/2016 |
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, while the product was sitting on the shelf at the hospital, it noticed that there was damage to the packaging as well as damage to the product inside the packaging.There were 2 holes in the packaging, there was a crushed luer cap at the bottom of the package and one of the cardiotomy luer ports were damaged.No patient involvement as this occurred during out of box.
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Manufacturer Narrative
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This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on september 22, 2016.(b)(4).The returned sample was visually inspected upon receipt.It was found that the packaging, breather bag, and luer port on the top of the reservoir lid were all damaged.The cap on the luer port was broken off of the port.A retention sample from the same product code/lot number combination was visually inspected and confirmed to have no damages.All capiox units are 100% visually inspected at several points in the production process.A review of the device history record revealed no manufacturing anomalies.(b)(4) - human factors issue was chosen because it is likely that the packaging and product were damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.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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