MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE+, UK

Model Number CSE-EW-UK

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the incident had no detrimental impact on patient or their health status, haemonetics is reporting based on the amount of blood lost.Haemonetics sent a field service engineer to evaluate the device and there were no malfunctions.The disposable sample was discarded, with no sample available for investigation haemonetics is unable to perform an evaluation.

Event Description

On (b)(6) 2021 haemonetics was notified of an early wash trigger which occurred during a procedure in the (b)(6), utilizing the cell saver elite.There was an estimated blood loss of 550ml.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE+, UK
• 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: 12547465
• MDR Text Key: 273810127
• Report Number: 1219343-2021-00129
• Device Sequence Number: 1
• Product Code: CAC
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSE-EW-UK
• Device Lot Number: 201022H1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• 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
• Patient Age: 31 YR