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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the unit collected during donation tested positive for gram+rods resembling bacillus.The microorganisms were found in the platelet storage bags.The time interval that these microorganisms were found was 17.2 hours.Single product; no bag attached; sampling device sterile welded.
Event or Problem Description
Customer reported the unit collected during donation tested positive for gram+ rods resembling bacillus.The microorganisms were found in the platelet storage bags.The time interval that these microorganisms were found was 17.2 hours.Single product; no bag attached; sampling device sterile welded.Investigation 599817 was completed.No samples were received for analysis.However, microbiological testing results were reviewed for amicus batch fa19e06138 manufacturing period, including previous month.No out of limit is observed in the 12-month timeframe.A microbiology testing external supplier, pace analytical, completed additional testing to the amicus manufacturing areas, including the following sampling: - environmental monitoring air samples.- surface monitoring swabs.- organism identification.The same sampling was taken by the haina microbiology lab team, to review the current amicus conditions.Root cause identified: the amicus microbiology testing was completed with satisfactory results.The bacteria identified by the customer is not part of the haina plant micro-flora.In addition, the microbiology monitoring is within established limit.Current controls: - microbiology monitoring.- product e-beam sterilization.- in process sampling quality inspection.- post sterilization sampling final inspection.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Common Device Name: AMICUS APHERESIS KIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• MDR Report Key: 9130454
• Report Number: 3004548776-2019-00017
• Device Sequence Number: 2376901
• Product Code: GKT
• UDI-Device Identifier: 04086000101387
• UDI-Public: 010408600010138710FA19E061381119050617200831
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: BK960005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019
• Report Date (Section F): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 4R2354
• Device Lot Number: FA19E06138
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/30/2019
• Event Location: Other
• Date Report to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1