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 05/04/2021

Event Type  Injury  

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 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
• 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: 11934760
• MDR Text Key: 254300248
• Report Number: 1219343-2021-00024
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)230804(10)0820012
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: CSE-P-125
• Device Lot Number: 0820012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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