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

Model Number CSE-P-125

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 06/17/2021

Event Type  Injury  

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 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
• Type of Device: CELL SAVER ELITE SET - 125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 12371310
• MDR Text Key: 268265925
• Report Number: 1219343-2021-00119
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230924(10)0920057
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 920057
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other