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

Model Number	M46444160
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they primed the tubing with saline first and it was during setup of putting the tubing in the pump that they noticed that it was leaking.They said what was coming out was most likely saline but they were hanging paclitaxel so some of the drug could have dripped out but not sure.The spill went onto the floor and was treated as a chemo spill.The customer stated none of the spilled liquid got on the patient or the nurse.The set was leaking next to the smart clip right at the pumping segment.A sample investigation could not be performed as we did not receive the actual complaint sample.We received video which showed leakage at blue safety clamp.However, based on the video, we cannot determine what was the cause of the leak.Without an actual sample a detailed analysis is unfortunately not possible.We performed a free flow and tightness test on one retain sample of the complaint batch and could not find any non-conformity.The review of our production documents did not show any deviations related to the complaint reason.Based on the investigation results, 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: 6226308
• Report Number: 9681819-2017-00035
• Device Sequence Number: 720979
• Product Code: FRN
• UDI-Device Identifier: 04250273714395
• UDI-Public: 04250273714395
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• PMA/510(K) Number: K121613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2016
• Report Date (Section F): 10/10/2016

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: M46444160
• Device Catalogue Number: N/A
• Device Lot Number: 32274166
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/07/2016
• Event Location: Other
• Date Report to Manufacturer: 10/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1