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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PLUS; APPARATUS, AUTOTRANSFUSION
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HAEMONETICS CORPORATION CELL SAVER ELITE PLUS; APPARATUS, AUTOTRANSFUSION Back to Search Results
Model Number CSE-EW-US
Device Problems Vibration (1674); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2018
Event Type  malfunction  
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
The following elements have blank data.
 
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Brand Name
CELL SAVER ELITE PLUS
Type of Device
APPARATUS, AUTOTRANSFUSION
Manufacturer (Section D)
HAEMONETICS CORPORATION
400 wood road
braintree MA 02184
MDR Report Key7613814
MDR Text Key111491248
Report Number7613814
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCSE-EW-US
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2018
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer06/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO; NO; NO OTHER THERAPIES; NO OTHER THERAPIES; NO; NO OTHER THERAPIES
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