MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	2443-0600
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer stated that during infusion the 60 gtt burette with the 0.2 micron filter, it leaks at the filter.There was no report of patient harm.
Event or Problem Description
The customer stated that during infusion the 60 gtt burette with the 0.2 micron filter, it leaks at the filter.There was no report of patient harm.
Additional Manufacturer Narrative
The customer report that the set leaks at the filter was not confirmed.Visual inspection showed dried residue on and around the area of the lower vent of the filter.Functional testing showed slight bubbling coming out from the filter's lower vent; however no leaks were observed.Pressure testing resulted in no leaking the root cause of the customer's report could not be identified.
Event or Problem Description
The customer reported the set leaked at the filter during an infusion on a nicu patient.There was no report of patient harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7763403
• Report Number: 9616066-2018-01299
• Device Sequence Number: 19133733
• Product Code: FPA
• UDI-Device Identifier: 10885403235061
• UDI-Public: 10885403235061
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2018

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: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: 2443-0600
• Device Catalogue Number: 2443-0600
• Device Lot Number: 18016905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/28/2018; 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1