Model Number CSE-EW-US |
Device Problems
Vibration (1674); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/05/2018 |
Event Type
malfunction
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Event Description
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Twelve brand new haemonetics cell savers were purchased (model = cell saver elite plus) between two campuses.Almost immediately after putting these devices in service the clinicians noticed strong vibrations and loud noises caused by the cover on the unit.The company was contacted and came in multiple times to readjust the cover without completely fixing the problem.Upon further investigation with the company, this issue was wide-spread and a full-remediation was found - replace the hinge on the cover.Haemonetics replaced all hinges on the devices and the vibration and noise issue was completely solved.These devices are used in open heart and lung procedures.The procedure was not impacted however the clinicians in the room had a hard time focusing and communication because of the vibration and the noise caused by the cover.Manufacturer response for cell saver autotransfusion, cell saver elite plus (per site reporter).The oem was aware of the problem and corrected the issue.
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Event Description
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12 brand new haemonetics cell savers were purchased (model = cell saver elite plus) between two campuses.Almost immediately after putting these devices in service the clinicians noticed strong vibrations and loud noises caused by the cover on the unit.The company was contacted and came in multiple times to readjust the cover without completely fixing the problem.Upon further investigation with the company, this issue was wide-spread and a full-remediation was found - replace the hinge on the cover.Haemonetics replaced all hinges on the devices and the vibration and noise issue was completely solved.These devices are used in open heart and lung procedures.The procedure was not impacted however the clinicians in the room had a hard time focusing and communication because of the vibration and the noise caused by the cover.Manufacturer response for cell saver autotransfusion, cell saver elite plus (per site reporter).The oem was aware of the problem and corrected the issue.
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Manufacturer Narrative
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Search Alerts/Recalls
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