MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE

Model Number CSE-E-US

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the cell saver elite.Haemonetics field service engineer was unable to duplicate reported issues, but found pinch valve cover assembly loose.The pinch valve cover assembly was upgraded and device met manufacturers specifications.The pinch valve cover assembly sample has yet to be returned to haemonetics, without physical sample the root cause could not be determined.

Event Description

On (b)(6) 2020, haemonetics was notified of a blood bag filling with saline instead of blood after a procedure, utilizing the cell saver elite.There was no reported impact to patients' health.

• Brand Name: CELL SAVER ELITE
• Type of Device: CELL SAVER ELITE
• 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: 11175478
• MDR Text Key: 241614770
• Report Number: 1219343-2020-00146
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-E-US
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2012
• 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