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

Model Number	2429-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 150ml baxter bag, lot: dr18g28063, intravia container; therapy date: (b)(6) 2019.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.
Event or Problem Description
It was reported that in the neonatal icu, the nurse primed the iv tubing, placed it in the pump module and it alarmed air in line.The nurse attempted to remove the air by flicking the tubing.The tubing separated at the upper fitment of the pumping segment and leaked an unspecified fluid.The customer states there was no harm.
Event or Problem Description
It was reported that in the neonatal icu, the nurse primed the iv tubing, placed it in the pump module and it alarmed air in line.The nurse attempted to remove the air by flicking the tubing.The tubing separated at the upper fitment of the pumping segment and leaked an unspecified fluid.The customer states there was no harm.
Additional Manufacturer Narrative
The customer¿s report of pumping segment separated at the upper fitment and leaked was confirmed.Visual inspection of the set noted that the silicone segment was completely separated away from the upper fitment.Further visual inspection of separated silicone segment end noted no o-ring indentations on the silicone segment.Examination under magnification noted no crush mark to the upper or lower blue fitment.Functional testing was deemed unnecessary due to a separation in the silicone tubing.Fluid was also observed to be leaking from the set.Dimensional testing was performed and the silicone tubing measured to be within specification.The root cause of the primary set silicone segment separation was due to the set's retainer ring not being assembled onto the set during manufacturing assembly process.

• 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: 8860978
• Report Number: 9616066-2019-02203
• Device Sequence Number: 2000402
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• 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
• Report Date (Section B): 07/11/2019

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 Expiration Date: 03/07/2022
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 19035413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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, 8100, NON-BD EXT SET, TD (B)(6) 2019; 8015, 8100, NON-BD EXT SET, TD (B)(6) 2019