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

Model Number	10933805
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the alaris pump infusion was in two pieces was confirmed as received.One opened and unused primary set model 10933805 lot 19076965 in its original packaging pouch.During visual inspection it was observed that the silicone segment was separated from the lower fitment at the pump segment.The ring retainer was not received with the set and a ring retainer indentation was not observed around the end of the silicone pump tubing where the separation occurred.Closer inspection under a lab microscope observed no indication of damage or tool marks on the pump segment.Functional testing could not be performed due to the set's separation and obvious leaking that would occur due to the separation.The silicone pump tubing was found to be within measurement specification.The root cause of the primary set silicone segment separation was due to the set's retainer ring not assembled onto the set during manufacturing assembly process.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "alaris pump infusion set removed from packaging and noted to be in two pieces." an incomplete date of event of (b)(6) 2019 was provided.It was reported that there was no delay in patient therapy.

• 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: 9221564
• Report Number: 9616066-2019-02917
• Device Sequence Number: 19372587
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 07/30/2022
• Device Model Number: 10933805
• Device Catalogue Number: 10933805
• Device Lot Number: 19076965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1