MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH AGILIA INFUSION SYSTEM; INFUSION PUMP SYSTEM

Model Number	M46441960
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/05/2015
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a leak from the green connector of the agilia infusion set.Per the customer no patient issues were reported for this event.A sample will not be returned and a batch number is not available for evaluation.The customer provided a picture of the incident for further evaluation.Since a sample is not available for evaluation a complete analysis could not be performed.The batch number is missing we were not able to check any retain samples or production documents.The received picture is not sharp enough and we were not able to confirm the leakage and its origin.Therefore, a root cause could not be determined.

• Brand Name: AGILIA INFUSION SYSTEM
• Common Device Name: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen D-362 51; GM D-36251
• MDR Report Key: 6223858
• Report Number: 9681819-2017-00030
• Device Sequence Number: 10864617
• Product Code: FRN
• UDI-Device Identifier: 04250273714272
• UDI-Public: 04250273714272
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2015
• Report Date (Section F): 11/12/2015

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: Other
• Device Model Number: M46441960
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/05/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2015
• Initial Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1