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

Model Number	C24101E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2019
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
It was reported that an during a tpn infusion iv bag was found to be empty after being initiated by the previous shift.Upon assessment, it was found that there was a hole located in the upper portion of the tubing set.
Additional Manufacturer Narrative
The customer¿s report of a hole in the tubing was confirmed.Functional priming testing observed a leak from the engagement between the tubing and tubing adaptor just below the drip chamber.Closer inspection of the leak under magnification observed a hole in the tubing.No other leaks were observed throughout the tubing.The root cause of the hole could not be identified.
Event or Problem Description
It was reported that an during a tpn infusion iv bag was found to be empty after being initiated by the previous shift in the picu department.Upon assessment it was found that there was a hole located in the upper portion of the tubing set.

• 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: 8807535
• Report Number: 9616066-2019-02007
• Device Sequence Number: 326800
• Product Code: FPA
• UDI-Device Identifier: 10885403235528
• UDI-Public: 10885403235528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 01/03/2022
• Device Model Number: C24101E
• Device Catalogue Number: C24101E
• Device Lot Number: 19015147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1