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

Model Number	2410-0500
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag, ndc 0338-0049-04 lot y293738, exp jul20, 0.9% sodium chloride injection; 50ml baxter bag, ndc 0338-5002-41, lot ld138833, exp 07nov19 ceftriaxone injection.Although requested, no patient details: dob, age ; gender; weight ; or diagnosis were available.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
It was reported that when secondary tubing was attached, the contents of the secondary bag immediately entered the primary bag.There was no patient harm reported.The user observed the issue, identified and addressed the problem directly.
Additional Manufacturer Narrative
The customer¿s report of backflow secondary to primary was not confirmed.No anomalies were observed on the received set during visual inspection.Functional testing showed no anomalies.Basic infusion testing showed no anomalies.A (qn) quality notification search showed no relevant issues for failure mode reported.The root cause of secondary infusion backed up into primary was not confirmed.
Event or Problem Description
It was reported that when the secondary tubing was attached, the contents of the secondary bag immediately entered the primary bag.There was no patient harm reported.The user observed the issue, identified and addressed the problem directly.
Event or Problem Description
It was reported that when secondary tubing was attached, the contents of the secondary bag immediately entered the primary bag.There was no patient harm reported.The user observed the issue, identified and addressed the problem directly.
Additional Manufacturer Narrative
Additional information: patient identifier, age.

• 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: 8649470
• Report Number: 9616066-2019-01391
• Device Sequence Number: 2075404
• Product Code: FPA
• UDI-Device Identifier: 07613203012492
• UDI-Public: 7613203012492
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2019

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: 2410-0500
• Device Catalogue Number: 2410-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 09/12/2019; 10/10/2019
• 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: 72213N, TD (B)(6) 2019; 72213N, TD (B)(6) 2019
• Patient Age: 68 YR