MAUDE Adverse Event Report: PLASMA DONATION SET; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

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

Patient Problem Hematoma (1884)

Event Date 05/21/2022

Event Type  Injury  

Event Description

Patient called to report an adverse event that occurred while he was donating plasma.Patient stated that when they were returning electrolytes back into him using the device, his arm blew up.The patient stated he left mad and upset, and was denied to donate again a couple days later.The patient stated he was a returning donor and has contacted the facilities hr department.

• Brand Name: PLASMA DONATION SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• MDR Report Key: 14522263
• MDR Text Key: 292983009
• Report Number: MW5109966
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male