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	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Patient received a donor transfusion as none of the processed blood could be reinfused due to the reported particles.Processed blood with black particles observed was not given to patient.The estimated blood loss was 250 ml.The samples were discarded by hospital as they stated there were very few particles present and it would be difficult to evaluate.Without returned sample, haemonetics was unable to evaluate to confirm complaint or determine root cause.
Event or Problem Description
On july 27, 2021 haemonetics was notified of unidentified black particles seen in rbc bag which was observed during a procedure in the (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125 ml.

• 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: 12371310
• Report Number: 1219343-2021-00119
• Device Sequence Number: 4115742
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230924(10)0920057
• 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): 07/27/2021

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: 09/24/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 920057
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/26/2021
• 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