Catalog Number 284580 |
Device Problems
Unknown (for use when the device problem is not known) (2204); Device Operates Differently Than Expected (2913)
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Patient Problems
Extravasation (1842); Surgical procedure, delayed (2565)
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Event Date 05/28/2015 |
Event Type
Injury
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Event Description
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It was reported by the customer that the pump was causing the tubing to collapse.Customer tried a second pump and the suction was running constantly.Customer stated that the patients shoulder had become swollen during the procedure and the procedure was prolonged for approximately one hour.No patient consequences.Both pumps being returned.See associated medwatch number 1221934-2015-00838.
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek, however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
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Manufacturer Narrative
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The complaint device was received and evaluated.Visual and functional testing revealed no anomies and the reported condition could not be duplicated.Further a review into the depuy synthes mitek complaints system revealed one dissimilar complaint for this device's serial number.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Event Description
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It was reported by the customer that the pump was causing the tubing to collapse.Customer tried a second pump and the suction was running constantly.Customer stated that the patients shoulder had become swollen during the procedure and the procedure was prolonged for approximately one hour.No patient consequences.Both pumps being returned.See associated medwatch number 1221934-2015-00838.
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Search Alerts/Recalls
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