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

Model Number	M46441360
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the transfusion set spike fell out of the iv bag causing a leak.The event did not occur during infusion and the iv bag was just hanging up on the pole.The customer had to use a chemo spill kit to clean the spill.The drug avastin got on the nurse but was not harmed.The drug spill did not get on the patient.The customer did not provide any sample, pictures or information regarding the batch number.Therefore, a detailed analysis could not be performed and 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: 6226866
• Report Number: 9681819-2017-00034
• Device Sequence Number: 13633552
• Product Code: FRN
• UDI-Device Identifier: 04250273714517
• UDI-Public: 04250273714517
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2016
• Report Date (Section F): 09/13/2016

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: M46441360
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1