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

Model Number	2477-0000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 250ml baxter bag ndc 0338-0049-02, lot number v18g14a, exp jan20, 0.9% sodium chloride.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
The customer reported that during a blood transfusion in the pediatric clinic, the set separated above the drip chamber which caused blood to spill.There's no report of patient harm.
Event or Problem Description
The customer reported that during a blood transfusion in the pediatric clinic, the set separated above the filtered drip chamber which caused blood to spill.There's no report of patient harm.The customer later reported this event "just happened last month.".
Additional Manufacturer Narrative
The customer¿s report that the set separated above the drip chamber which caused a leak was confirmed.Visual inspection observed a separation between the top of the blood filter drip chamber (p/n 600093) where one of the two tubing lines (p/n 660134) enter.Closer inspection identified insufficient solvent at the engagement between the tubing and the top drip chamber ports.Dimensional analysis was within specification.The root cause of the customer's report was not determined.
Additional Manufacturer Narrative
Correction: event.
Event or Problem Description
The customer later reported this event ".Just happened last month.".

• 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: 8143585
• Report Number: 9616066-2018-02402
• Device Sequence Number: 16208921
• Product Code: FPA
• UDI-Device Identifier: 07613203011310
• UDI-Public: 7613203011310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2018

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: 08/11/2021
• Device Model Number: 2477-0000
• Device Catalogue Number: 2477-0000
• Device Lot Number: 18085939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/10/2019; 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1