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

Model Number	2200-0500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 tubing separated.There was no patient involvement.There was no user harm.
Event or Problem Description
It was reported that the tubing separated.It was confirmed during follow up, that there was no patient involvement and there was no user harm.
Additional Manufacturer Narrative
The customer¿s report that that tubing separated was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection confirmed that the tubing was completely separated from the tubing adapter due to insufficient solvent being applied at the engagement of the tubing.There were no other anomalies observed with the set during initial inspection.The tubing and tubing adapter was measured and found to be within specification(s).Functional testing could not be conducted due to the set being separated.The root cause was a manufacturing issue for insufficient solvent being applied at the engagement of the tubing due to equipment and/or operator error.

• 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: 9363838
• Report Number: 9616066-2019-03437
• Device Sequence Number: 2114679
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 7613203012638
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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,Followup
• Report Date (Section B): 11/06/2019

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: 01/09/2022
• Device Model Number: 2200-0500
• Device Catalogue Number: 2200-0500
• Device Lot Number: 19015602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1