MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE+, UK; CSE-EW-UK

Model Number CELL SAVER ELITE+, UK

Device Problem No Pressure (2994)

Patient Problem Blood Loss (2597)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Patient was reported to have no adverse reaction for this event; however, lost 10 liters of blood during the procedure.A loss of 3.5 liters of blood was due to vaginal bleeding that could not be salvaged.A field service engineer was dispatched and inspected the machine and replaced a pinch valve bushing.Diagnostics checks were run and unit meets manufacturers' specifications.The disposable processing kit that was used in this event was discarded.This event occurred in the united kingdom with a product that is not registered or marketed within the us.However, haemonetics has a similar device marketed and cleared for use by the fda where the alleged malfunction can potentially occur.This report is being filed due to the reported failures that could occur on a similar device marketed and cleared for use by the fda.

Event Description

On (b)(6) 2020, haemonetics was informed by the customer of an adverse event and device malfunction and adverse event that happened during a gynecological procedure.A long empty alarm was sounded and a second machine was brought in to finish the procedure.

• Brand Name: CELL SAVER ELITE+, UK
• Type of Device: CSE-EW-UK
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9860216
• MDR Text Key: 185674023
• Report Number: 1219343-2020-00020
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CELL SAVER ELITE+, UK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other