Catalog Number C-CB-1000 |
Device Problems
Connection Problem (2900); Mechanics Altered (2984)
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Patient Problem
No Information (3190)
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Event Date 10/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, while hooking up the blower mister to a co2 tank there was no connector on the braided line and the line was shorter than usual and the disk filter was just shoved inside the tubing.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.The blue connector was intact and showed no signs of defects.Only one part of the blow mister was returned.The braided (0.64 cm) was intact and no visual defects were observed.No iv tubing was returned.Based on the condition of the returned device, the reported complaint "missing component" was not confirmed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, while hooking up the blower mister to a co2 tank there was no connector on the braided line and the line was shorter than usual and the disk filter was just shoved inside the tubing.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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