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

Model Number	C24101E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer report that the filter¿s air vent leaked was confirmed.The set was visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.Light brown liquid was observed inside the 0.2 micron adult filter (p/n 10012217) and tubing throughout the set.Sticky residue was also observed on the surface of the filter.No anomalies or evidence of damage were observed at the filter or throughout the set upon visual inspection.Functional testing was performed by spiking the primary set to one lab iv bag filled with blue dye water and repriming the set via gravity.After disengaging the clamps, small droplets were observed leaking from the 0.2 micron adult filter¿s top air vent (termed ¿weeping out¿).The primary set was pressure tested while submerged underwater.Air pressure was incrementally increased.At 3 psi, a leak was observed at filter¿s vent, confirming the customer¿s report.Pressure was increased to 30 psi but no other leaks were observed.The root cause of the leak was not identified.
Event or Problem Description
It was reported that during priming tpn, the filter air vent leaked.The leak was discovered after the new tpn bag and tubing were hung but did not involve a patient.

• 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: 8913589
• Report Number: 9616066-2019-02296
• Device Sequence Number: 11262811
• Product Code: FPA
• UDI-Device Identifier: 10885403235528
• UDI-Public: 10885403235528
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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 Model Number: C24101E
• Device Catalogue Number: C24101E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1