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

Model Number 00205-00

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

While using the cell saver 5+ machine, bloody fluid leaked into the centrifuge causing entire product to be discarded.Open heart surgery case.Two full runs were washed and ready to reinfuse.While collecting a third run, leak occurred.Unable to confirm sterility of washed product, so all blood was tossed.This patient may require a blood transfusion later in his recovery.

• Brand Name: HAEMONETICS CELL SAVER SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• MDR Report Key: 12376827
• MDR Text Key: 268482407
• Report Number: 12376827
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/23/2021,08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00205-00
• Device Catalogue Number: 00205-00
• Device Lot Number: 0620146
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA