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

Model Number	10406194
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 100ml baxter bag, lot: p390583, exp: sep20, 0.9% sodium chloride injection; therapy date unknown.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that the filter was leaking 0.9% sodium chloride.Although requested, additional information was not provided.
Event or Problem Description
It was reported that the filter was leaking 0.9% sodium chloride.Although requested, there has been no patient impact outcome response or further event information made available to date.
Additional Manufacturer Narrative
The reported complaint of leaking from the 0.2-micron filter was confirmed.The set were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed that the inlet port tubing was completely broken off and detached from the set¿s micron filter.The filter inlet port pivot was observed to be broken off and still inside the tubing sleeve.Stress marks were observed on the area where the inlet port pivot was attached to the filter body.There were no other anomalies.No functional testing was feasible due to the damage to the set¿s filter.Dimensional analysis was not able to be performed as part of the filter¿s inlet port pivot that connects to the tubing, was broken off and was inside the tubing.The root cause of the reported complaint that the filter was leaking 0.9% sodium chloride was found to be the result of a broken engagement at the micron filter inlet port.

• 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: 9386878
• Report Number: 9616066-2019-03488
• Device Sequence Number: 19392518
• Product Code: FPA
• UDI-Device Identifier: 10885403234224
• UDI-Public: 10885403234224
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 10406194
• Device Catalogue Number: 10406194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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: SEE H.10.