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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAEMONETICS, INC. CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML

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HAEMONETICS, INC. CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML Back to Search Results
Model Number CSE-P-125-JA
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
On (b)(4) 2021 haemonetics manufacturing performed a visual inspection of the received bowl from the cell saver® elite set - 125ml and confirmed blood in the inner core with a crack in the inner core base.Although there was no serious injury or patient harm, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 1219343-2020-00001-01 indicated the inner core of the bowl malfunctioned via a crack but did not cause or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due to the event of the past report.
 
Event Description
On (b)(4) 2021, haemonetics was notified of an error message of long-term blood return was displayed and the operation was stopped.In japan utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.There was no reported impact to the health of the patient.
 
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Brand Name
CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
Type of Device
CELL SAVER ELITE SET - 125ML
Manufacturer (Section D)
HAEMONETICS, INC.
125 summer street
boston MA 02110
Manufacturer (Section G)
HAEMONETICS, INC.
125 summer street
boston MA 02110
Manufacturer Contact
brenda bruyere
125 summer street
boston, MA 02110
MDR Report Key12933360
MDR Text Key285831950
Report Number1219343-2021-00149
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,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCSE-P-125-JA
Device Lot Number0521020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2021
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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