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

Model Number N/A

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

Patient Problem Fever (1858)

Event Date 07/02/2023

Event Type  Injury  

Event Description

Fresenius kabi china received a suspected adverse event involving an amicus kit (material c6r2316, batch fa23a13053).Per the reporting hospital, a patient had a fever after an infusion of one unit of platelets.The hospital reports the second unit of platelets donated by the same donor was also contaminated with bacteria.The hospital checked the stored platelets and found a total of 10 units of platelets potentially contaminated with bacteria collected with amicus kits (material c6r2316, batch fa23a13053).The 10 potentially contaminated platelets came from 5 different kits with batch fa23a13053 and 5 different donors.There appears to be some confusion on which platelets are suspected to have bacterial contamination versus platelet aggravation based on pictures and videos provided thus far.The reporting hospital performed a bacterial culture of the contaminated platelets and the environment of the collection room on (b)(6), 2023, but it is currently unknown which units were tested (those from the adverse event or other unit(s).The bacterial culture identified staphylococcus aureus and staphylococcus epidermidis in all contaminated platelets including those that were identified as abnormal visually.Per the china clinical support team, based on internal policy, the hospital is refusing to provide the platelet samples for investigation.Per the reporting hospital, the donation skin prep technique used for the reported platelet donations is as follows: 3 steps to the skin prep before collection (1) clear the cubital fossa with running water (2) wipe the skin with chlorhexidine (3) iodophor cotton swab the hospital treats the collected platelets with co 60 radiation for 40 minutes.The cold chain system is used for platelet transport in the reporting hospital.The temperature control is 23-25c during collection and storage, and 22±1c during shaking.All collections were prepped between two collection rooms that are very close to each other.The same technique was performed in both collection rooms.No leaks were detected in the amicus kits during collection, storage or transport.The hospital has been using the fresenius kabi amicus device and disposables for many years.During donation, the 0.9% saline solution manufactured by huaren pharmaceutical and acd solution manufactured by nigale were used.The solutions used in the platelet donations were the same batches for all reported cases.The hospital did not culture the ac or saline solution bags.Follow-up was made to the hospital to request solutions of the same batch used in the reported platelet donations be returned for evaluation.The hospital will not be providing the solutions to fresenius kabi for evaluation.A total of (b)(4) amicus kits (material c6r2316, batch fa23a13053) were imported to china.(b)(4) kits have been distributed to customers and (b)(4) unused kits were sent to the manufacturing plant for investigation.There is no remaining inventory of amicus kits (material c6r2316, batch fa23a13053) in the china warehouse.The amicus kits (material c6r2316, batch fa23a13053) were delivered to customers starting (b)(4), 2023.There are no additional contamination complaints reported against batch fa23a13053 from other end users.Fresenius kabi's investigation is in process.

Event Description

No sample was returned to fresenius kabi usa for evaluation.Pictures of the platelet bag filled with collected product were observed.However, based on the complaint description, it is not possible to confirm the customer report of bacterial contamination from the provided pictures.The batch record for product code: c6r2316, lot: fa23a13053 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.Root cause: event#: 1627726 was issued in order to investigate this condition.The amicus microbiology testings were completed with satisfactory results.The bacteria identified in the complaints was not found during the haina plant micro-flora during the manufacturing period of the reported batches.Studies were performed to confirm that the microorganisms reported do not resist the sterilization process.No further investigation is required.Current controls: microbiology monitoring, product e-beam sterilization, in process sampling quality inspection.Post sterilization sampling final inspection.Track and trend: fresenius kabi china reported a total of 5 bacterial contamination incidents against product code: c6r2316, lot: fa23a13053.A monthly trend is performed to determine the need to initiate an investigation due to an increase in complaints or to determine if corrective actions are needed.No trend was observed for this defect category.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: AMICUS APHERESIS KIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 17446038
• MDR Text Key: 320289467
• Report Number: 3004548776-2023-00261
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/31/2024

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 Model Number: N/A
• Device Catalogue Number: C6R2316
• Device Lot Number: FA23A13053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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): Other