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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORPORATION HAEMONETICS CELL SAVER; CELL SAVER ELITE
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HAEMONETICS CORPORATION HAEMONETICS CELL SAVER; CELL SAVER ELITE Back to Search Results
Model Number ELITE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Blood Loss (2597)
Event Date 11/19/2019
Event Type  Death  
Event Description
Cell saver used for bloodless medicine pt, who underwent robotic assisted laparoscopic bilateral ovarian cystectomy for endometriosis.Surgery progressed normally.Est blood loss 300ml.At conclusion, when closing skin and returning blood to pt, the pt went into cardiac arrest.Pt expired despite resuscitation efforts.Preliminary autopsy found microthrombi consistent with endometrial material in all lobes of both lungs.
 
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Brand Name
HAEMONETICS CELL SAVER
Type of Device
CELL SAVER ELITE
Manufacturer (Section D)
HAEMONETICS CORPORATION
400 wood rd
braintree MA 02184
MDR Report Key9429184
MDR Text Key169811913
Report Number9429184
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberELITE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/04/2019
Distributor Facility Aware Date11/19/2019
Event Location Hospital
Date Report to Manufacturer12/04/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/06/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age25 YR
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