MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MX9166
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: non bd spiros adapter.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient age and dob requested but not provided, however, the event reportedly occurred on the pediatric oncology department, therefore it is presumed that the patient was a pediatric patient.
Event or Problem Description
It was reported that the tubing set filter was found to have leaked from the "circle area" on the backside of the filter prior to the initiation of a chemotherapy infusion in the pediatric oncology department.
Additional Manufacturer Narrative
The customer¿s report that the tubing set filter leaked from the vent was confirmed.Inspection noted the air vent membrane of the 0.2 micron filter was wetted/compromised and testing observed a leak (termed ¿weeping out¿) from the same area.The possible causes of the observed filter vent leak, based on previous investigations, are likely due to infusate clog/oversaturation of filter, or time in use to the extent that fluid flow is restricted, and/or fluid resistance.Testing was performed by allowing/pushing fluid through.It was observed that the fluid only leaked out from the vent of the 0.2 micron filter.No leaks or any other issues from anywhere were observed.Further pressure testing the set up to 30psi while submerged underwater observed no unexpected leaks or any issues.The root cause was not identified.
Event or Problem Description
It was reported that the tubing set filter was found to have leaked from the "circle area" on the backside of the filter prior to the initiation of a chemotherapy infusion in the pediatric oncology department.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8907992
• Report Number: 9616066-2019-02288
• Device Sequence Number: 11445725
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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 Expiration Date: 01/30/2024
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 19017181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,PRI TUBING,8100,THERAPY DATE UNKNOWN; NON BD PRIMARY TUBING SET