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

Model Number	M46441960
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/15/2015
Type of Reportable Event	Malfunction
Event or Problem Description
On dec 15,2015 an fresenius (b)(4) employee called in a report from (b)(6).The customer reported a chemo leak during use occurring distal to the safety clamp.No patient injury or adverse reaction was reported.The customer stated no sample is available to be returned for evaluation, but pictures are available.An update from the fresenius-(b)(4) representative to correct her statement, leak occurred proximal to the safe clip, where the safe clip meets the pumping segment.She also stated that pictures were available.Investigation: we did not receive a sample but a photo for investigation.Based on the picture we found a drop of liquid under the silicon tube however using the picture we unfortunately could not determine the exact complaint reason or the root cause.We performed a free flow and tightness test on one retain sample of the complained batch without finding any non-conformity.The investigation of the production documents did not show any deviations related to the complaint reason.Without an affected sample a more detailed analysis is unfortunately not possible.The root cause for this complaint reason is not known as we did not receive the sample.As we received similar complaints regarding leakages the following measures are implemented and a corrective and preventive action were started to analysis the exact root cause.
Additional Manufacturer Narrative
(b)(4).

• 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: 6206709
• Report Number: 9681819-2016-00050
• Device Sequence Number: 16334366
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2015
• Report Date (Section F): 12/16/2015

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?: Yes
• Operator of Device: No Information
• Device Model Number: M46441960
• Device Lot Number: 32173305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Report to Manufacturer: 12/16/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2015
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 03/28/2017; 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention