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

Catalog Number CSE-P-224

Device Problem Defective Device (2588)

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

Event Date 02/05/2020

Event Type  malfunction  

Event Description

First bowl of cell saver product was watery.Spun hct = 7.Product was returned to reservoir and added to second bowl.

• Brand Name: CELL SAVER ELITE SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer st; boston MA 02110
• MDR Report Key: 9882634
• MDR Text Key: 185017945
• Report Number: 9882634
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CSE-P-224
• Device Lot Number: 1219014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA