MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER® 5+ AUTOLOGOUS BLOOD RECOVERY SYSTEM; CS5+,220V ENG,LN02005-220-EP

Model Number 02005-220-EP

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Another machine was brought in to complete the procedure with no issues however there was a delay in blood reinfusion.A field service engineer was dispatched but due to the lockdown in france because of the covid-19 virus the unit will be inspected at a later date.

Event Description

On (b)(6) 2020, haemonetics was informed by the customer of a device malfunction resulting in the machine shutting off 3 times.

• Brand Name: CELL SAVER® 5+ AUTOLOGOUS BLOOD RECOVERY SYSTEM
• Type of Device: CS5+,220V ENG,LN02005-220-EP
• 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: 9889879
• MDR Text Key: 185674041
• Report Number: 1219343-2020-00028
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K932890
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02005-220-EP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2008
• 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 Age: 78 YR
• Patient Weight: 81