Model Number 3CX*RX25RW |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/27/2015 |
Event Type
malfunction
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Event Description
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The user facility reported to terumo cardiovascular systems corporation that visible cracking on the top of the reservoir at the venous inlet port was discovered out of box.No patient involvement as this occurred out of box.
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Manufacturer Narrative
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Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information become available.(b)(4).
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Manufacturer Narrative
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The actual device was visually inspected upon receipt revealing that the molded pulps were cracked and torn on the reservoir lid.The damage to the lids indicates that they were subjected to an external force causing the lids to fracture.Since the product is 100% visually inspected and leak tested during the manufacturing process, the reported damage is most likely due to excessive force to the reservoir post manufacturing; however the cause of the damage is unknown.A review of the device history record revealed there were no production related anomalies.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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