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

Model Number	10013037
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported that the bilateral tubing just above tubing chamber on the blood set leaked contains all over the floor while connected to a patient.There was no patient harm.
Additional Manufacturer Narrative
The customer report that the tubing above the blood drip chamber on the blood set leaked was confirmed.Testing and inspection was performed; a leak was observed from one of the two tubing engagements to its corresponding inlet port on the top of the blood filter drip chamber component.Further handling/tug of the tubing engagement on the top of the blood filter drip chamber component noted that the pvc tubing separated.Further visual inspection of the separated tubing end identified insufficient to no areas of the expected solvent.The root cause of the leak and subsequent separation was due to a manufacturing assembly issue of insufficient solvent being applied at the engagement of the tubing and the top of the drip chamber.
Event or Problem Description
The customer reported that the bilateral tubing just above the blood filter drip chamber on the blood set leaked blood contents onto the floor while infusing on a patient.There was no report of patient harm.

• 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: 8105989
• Report Number: 9616066-2018-02328
• Device Sequence Number: 19339639
• Product Code: FPA
• UDI-Device Identifier: 10885403233784
• UDI-Public: 10885403233784
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 09/08/2021
• Device Model Number: 10013037
• Device Catalogue Number: 10013037
• Device Lot Number: 18095497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1