MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML

Model Number	CSE-P-125
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Haemonetics sent a field service engineer to evaluate the cell saver® elite® autotransfusion system, it was determined that there was no detected problem with the system.Customer stated that the bowl was inspected and no visible cracks were observed.Although no cracks were determined by customer, haemonetics did not receive the sample back for evaluation to determine cause.
Event or Problem Description
On may 04, 2021 haemonetics was notified of a long hour returning error which was observed during a vascular procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.During the procedure it was also noted that there were prior error messages of pressure in blue line and fluid detected early.There was 293mls of blood was lost, and patient did require a post-operative transfusion.Customer stated there were unable to provide current patient health status due to confidentiality.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Common Device Name: CELL SAVER ELITE SET - 125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11934760
• Report Number: 1219343-2021-00024
• Device Sequence Number: 19999134
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230804(10)0820012
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0820012
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/03/2021
• 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: Other