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

Model Number	2450-0500
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the tubing broke and leaked could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.(b)(6).
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "patient was in ct scan, to receive iv contrast through her portacath iv was connected to iv infusion pump at 20ml/hr iv tubing clamped at the roller clamp mid tubing and distal port clamp.Iv contrast infusing and tubing broke at top of iv infusion pump at connector above soft tubing, leaking normal saline." the event occurred in the emergency department.There was no patient harm.It was confirmed that the iv contrast was given above the smartsite iv pump module.

• 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: 8879569
• Report Number: 9616066-2019-02268
• Device Sequence Number: 16206608
• Product Code: FPA
• UDI-Device Identifier: 10885403235115
• UDI-Public: 10885403235115
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: 2450-0500
• Device Catalogue Number: 2450-0500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial 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
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8100, THERAPY DATE (B)(6) 2019
• Patient Age: 80 YR
• Patient Weight: 33