MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM; CS5,220V ENGL,LN 02005-220-E

Model Number 02005-220-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

Limited donor/patient information was provided at this time.Haemonetics has not received any additional information regarding donors condition or medical outcome.A haemonetics field service engineer evaluated the suspected device and found that the unit meets all specifications, there were no faults observed.

Event Description

On (b)(6) 2018 haemonetics was notified of an adverse reaction which had occurred during a cell savage procedure, utilizing the cell saver® 5 autologous recovery system.The cell savage procedure was discontinued after 4 attempts to reinfuse donor were made.The donor experienced hypotensive reactions which worsened on each infusion attempt, the fourth and final attempt was terminated after only 10ml of salvaged rbcs were infused to the patient.Donor was transferred to the hospital.

• Brand Name: CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM
• Type of Device: CS5,220V ENGL,LN 02005-220-E
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 9896328
• MDR Text Key: 185672256
• Report Number: 1219343-2018-00046
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K014083
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02005-220-E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2002
• 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): Hospitalization