MAUDE Adverse Event Report: HAEMONETICS CORP MCS® + 8150; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 08150-110-E

Device Problem Obstruction of Flow (2423)

Patient Problems Weakness (2145); Dizziness (2194)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

A haemonetics field service engineer evaluated the device.Functional diagnostics of the device were performed.The procedure records were downloaded and verified.Verified configuration, calibration and device operation and all values were found within specification.No calibration was required.The unit meets manufacturer's specifications and was returned to service.

Event Description

Haemonetics was notified on (b)(6) 2016 that clotting was observed in the plasma bag of a double red cell donation and the donor was notified and sent to a medical facility.Upon follow up with the customer, it was determined that during the second return cycle of the donation, the machine gave a w36 alarm notifying the operator that the plasma weight was decreasing too slowly for the procedure.This is when the staff observed that there was a clot in the plasma bag.The procedure was then discontinued.The donor began to complain of weakness in his legs, dizziness and not feeling well.Nine-one-one (911) was called and the donor was transported to a local medical facility.Follow up with the donor determined he was later released from the hospital, but no other information was available.

• Brand Name: MCS® + 8150
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 5591922
• MDR Text Key: 43161752
• Report Number: 1219343-2016-00024
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK090004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 08150-110-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2006
• 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
• Patient Age: 55 YR
• Patient Weight: 84