MAUDE Adverse Event Report: FRESENIUS KABI WARRENDALE ALYX APHERESIS DOUBLE RED CELL LR KIT; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Lot Number X4R5720

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

Patient Problem Swelling/ Edema (4577)

Event Date 01/08/2022

Event Type  Injury  

Event Description

Donor (b)(6) was donating apheresis double red cells on an alyx machine on (b)(6) 2022 using kit lot # x4r5720.After approximately 20 minutes the donor developed a swollen face.The collection was immediately stopped at 9:16 am and the medical director was notified.The donor was given water, advised to take slow deep breaths and the donor's feet were elevated.The donor's blood pressure and pulse were taken on three occasions 15 minutes apart and all results were acceptable.The final check was at 9:50 am.The donor stated that he was feeling fine.The donor did not want to go to the hospital and went home with his wife at 10:00 am.Follow-up with the donor revealed that he took otc benadryl.The edema/swelling dissipated slowly over 4 days.Upon investigation, the donor has three prior apheresis double red cell donations on an alyx machine with no known reactions.The actual machine (alyx id # (b)(4)) showed no issues, the machine was working as expected.Fda safety report id # (b)(4).

• Brand Name: ALYX APHERESIS DOUBLE RED CELL LR KIT
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): FRESENIUS KABI WARRENDALE
• MDR Report Key: 13290249
• MDR Text Key: 284150118
• Report Number: MW5106780
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2022

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Lot Number: X4R5720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male