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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML
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HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML Back to Search Results
Model Number CSE-P-125-JA
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/29/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information was provided at this time.The bowl from the cell saver elite set was returned and evaluated by haemonetics.It was noted during investigation that blood was seen on the inner core.Bowl decompression testing confirmed the blood outflow from the inner core and the outer core welding.
 
Event Description
On january 8 2020 haemonetics was notified of a 117 returning error message which was displayed during a cardiac procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.There was no reported impact to patients' health.
 
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Brand Name
CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
Type of Device
CELL SAVER ELITE SET - 125ML
Manufacturer (Section D)
HAEMONETICS CORPORATION
125 summer street
boston, ma
Manufacturer (Section G)
HAEMONETICS CORPORATION
125 summer street
boston, ma
Manufacturer Contact
janice kiser
125 summer street
boston, ma 
MDR Report Key10221889
MDR Text Key197932591
Report Number1219343-2020-00054
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120586
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2022
Device Model NumberCSE-P-125-JA
Device Lot Number0519063
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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