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

Model Number	10062818
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 250ml baxter bag, lot: y326660, exp: jun21, 0.9% sodium chloride injection; td unk.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
An unexpected tubing set was received and it appeared the tubing had separated.No further information is available.
Additional Manufacturer Narrative
The unexpected returned set was observed to be tubing being separated.During visual inspection, it was noted that the vinyl tubing p/n (b)(4), was completely separated from the drip chamber p/n (b)(4), outlet port.Inspection under microscope also observed a gap of the tubing not being fully inserted into the drip chamber outlet port and traces of insufficient solvent on the tubing.The tubing was found to be within specification.No functional testing of the returned set was deemed unnecessary due to a separation.The root cause of the separation is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.
Event or Problem Description
An unexpected tubing set was received and it appeared the tubing had separated.No further information is available.

• 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: 10113324
• Report Number: 9616066-2020-01848
• Device Sequence Number: 2115467
• Product Code: FPA
• UDI-Device Identifier: 07613203019668
• UDI-Public: 7613203019668
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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): 05/12/2020

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: 10062818
• Device Catalogue Number: 10062818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1