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

Model Number	2433-0007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 from the hoi med surgical floor that a primary tubing set leaked.There was no report of harm to the patient or any medical professional.
Additional Manufacturer Narrative
Additional info: event date.The customer's report that primary tubing set leaked was not confirmed.Visual inspection showed no anomalies.Functional testing showed no anomalies.Dimensional analysis of the primary set's male luer component was measured to be within iso specification.The root cause of the customer's report was not identified.The device history record for model 2433-0007 lot 19096973 shows the set was manufactured on 30sep2019 with a total of 4,583 units built.There were no quality notifications issued during the production build of this set.
Event or Problem Description
It was reported from the hoi med surgical floor that a primary tubing set leaked.There was no report of harm to the patient or any medical professional.

• 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: 10064418
• Report Number: 9616066-2020-01672
• Device Sequence Number: 665530
• Product Code: FPA
• UDI-Device Identifier: 10885403227974
• UDI-Public: 10885403227974
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/27/2020

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: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: 2433-0007
• Device Catalogue Number: 2433-0007
• Device Lot Number: 19096973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: 30262E, TD: UNK.; 30262E, TD: UNK.