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

Model Number	M46441360
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Chemical Spillage (2894)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the set was broken below the drip chamber.The infusion treatment had not been started as the customer was putting the treatment on the pole.The drug came into contact with the nurse, but she was not harmed.The drug did not spill on the patient.The leak was cleaned up using a chemo spill kit.There was no sample returned, but pictures were available for review.The batch number is unknown.The inspection of the provided photographs showed a visible hole in the silicone tube (it is a part of the pump segment) next to the transparent adapter.The pvc tubes and drip chamber were found to be separated.A visible mark of the drip chamber connector (this is the point where the tubing is pushed) was also present.Without the batch number, the production documents could not be investigated and no retain samples could be tested.The cause of the leak was likely due to insufficient glue applied on the tube during the manufacturing process.A capa was initiated in the production facility to address this manufacturing issue.

• 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: 6226596
• Report Number: 9681819-2017-00033
• Device Sequence Number: 82424
• 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
• 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: Nurse
• Device Model Number: M46441360
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/12/2016
• Event Location: Outpatient Treatment Facility
• 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
• Outcome Attributed to Adverse Event: Other