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	Chemical Exposure (2570)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the set was leaking due to the spike disconnecting from the bag during setup while at patient bedside.The set was leaking the drug gemzar and the nurse and patient were exposed by direct contact to the drug.The nurse taped the iv bag to the set with pharmacy tape and it is still not holding them together.Due to the exposure to the drug the nurse and patient had to wash up with soap and change their clothes.An investigation could not be performed since there was no sample, no pictures and no batch number available.Therefore, a root cause could not be determined.
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: 6223852
• Report Number: 9681819-2017-00028
• Device Sequence Number: 893150
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2016
• Report Date (Section F): 09/22/2016

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: Nurse
• Device Model Number: M46441360
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 03/28/2017
• 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