Model Number CWIII ARTHROSCOPY PUMP |
Device Problem
Pumping Problem (3016)
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Patient Problems
Extravasation (1842); Pain (1994); Rupture (2208)
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Event Date 07/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device is expected but was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that during an arthroscopic partial resection surgery of the inner meniscus right knee the device has not maintained the set pressure value and has continued to pump.This presumably led to a rupture of the capsule and to a pronounced accumulation of water in the patient's thigh.A safety check was carried out properly before the surgery.The device also worked properly during a previous operation.The patient has an extravasation on the right thigh.Additional information obtained 7/16/2018: the facility performed the clamp test before surgery.During the surgery there was no alarm or error massage.The surgeon did not use arthrex tubings, he used tubings from another manufacturer (meise).It is not possible to send back the tubing because it was discarded by the facility.Because of the incident the patient needed to stay one day longer at the hospital.He is complaining about increased pain perception.The water was not completely removed - it will resorb itself.At the time of this report the surgeon can't tell if there are consequential damages for the patient because it's to early to tell.
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Manufacturer Narrative
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The evaluation did not reveal anything relevant to the event.The pump ran correctly with no issues noted and alerted "over pressure-pump paused" on screen and with an audible tone as the flow was clamped off.The unit did not continue to pump during the over pressure alert.Based on the information provided and device evaluation, the most likely cause(s) of this type of event is or procedures related to the set-up of the device and tubing did not conform to instructions provided or by the end user.On the tubing package, there is a label instructing the user as follows: warning: do not reconnect tubing for any reason.Reconnecting tubing that was disconnected may cause pump pressure monitoring system errors which may cause extravasation that could result in serious patient injury.In addition to equipment set-up, the operative joint capsule may have already been compromised from prior (preoperative) injury or trauma.
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Search Alerts/Recalls
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