MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AMICUS SEPARATOR SYSTEM; AMICUS PLATELET KIT

Catalog Number L6R2337

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

Patient Problems Dizziness (2194); Numbness (2415); Paresthesia (4421)

Event Date 04/26/2023

Event Type  Injury  

Event Description

Fresenius kabi received a report that due to a citrate reaction during an apheresis procedure, calcium carbonate 500mg (tums) and saline was given to a donor halfway through the procedure.The donor reported feeling better and the donation continued.At the end of the donation, the donor presented with paresthesia, stiffness in hands and feet, numbness of the face and a tingling sensation.The donor was then given another 500mg calcium carbonate tablet.No improvement was evidenced, so the donor was sent to the emergency department.In the emergency department, serum tests were performed, and low levels of calcium were found.No additional information was able to be ascertained for this event and it is unknown what treatment was received by the donor in the emergency room.It was reported that they were hospitalized for a day and a half.Although these are known possible side effects of an apheresis procedure, fresenius kabi is reporting this event conservatively as it is not known what treatment the donor was given in the hospital.".

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: AMICUS PLATELET KIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, dom, ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, dom ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 17794821
• MDR Text Key: 324006767
• Report Number: 3004548776-2023-00316
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: BK960005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: L6R2337
• Device Lot Number: FA23B14083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization