MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PROCESSING SET (225 ML)

Model Number	CSE-P-225
Medical Device Problem Codes	Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer went onsite to gather data on the procedure and discovered the leak occurred on cycle 4, with the total volume reinfused of 625ml during the procedure.The bowl was returned to haemonetics for evaluation.Evaluation of the returned bowl confirmed that a leak did occur in the inner core where the bowl base joins with the outer part of the inner core.This could be the possible cause of the leak at the dynamic seal however, it was not possible to confirm due to the condition of the returned sample.There is nothing at this time that would indicate that the death was related to the machine used.It was mentioned by the customer used another cell saver and a new set was used, to continue the procedure, but no further information was provided.
Event or Problem Description
On 16 december 2019: haemonetics was informed by the customer of a patient death the next day after surgery.During a surgery with the cell saver elite processing set emitted an alarm for "liquid in the centrifuge".It was reported there was a loss of 250ml in the bowl and from the bowl reservoir.The leak occurred on cycle 4, with a total volume reinfused of 625ml during the procedure.
Additional Manufacturer Narrative
The following sections were updated to reflect the results of the device evaluation: b1: product problem checked.The investigation determined the device did malfunction.H6: codes for device, results and conclusion were updated to reflect the investigation.The leak in the bowl could contribute to the error liquid in the centrifuge received by the customer during the procedure.The most likely cause of the leak is a crack in the inner core.However, cause of the device malfunction contributing to the adverse event could not be established based on the available information provided from the customer.

• Brand Name: CELL SAVER ELITE PROCESSING SET (225 ML)
• Common Device Name: CELL SAVER ELITE PROCESSING SET (225 ML)
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 9644075
• Report Number: 1219343-2020-00001
• Device Sequence Number: 2140071
• Product Code: CAC
• UDI-Device Identifier: 10812747016544
• UDI-Public: (01)10812747016544
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CSE-P-225
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR