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

Model Number	2232-0007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2019
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.Patient age and dob requested but not provided.However, the event reportedly occurred in the pediatric department, therefore, it is presumed the patient was a pediatric patient.
Event or Problem Description
The customer reported that the pediatric department experienced a large bore iv tubing set that separated and leaked below the filter during patient use.The tubing set was replaced with a new set.Other than the increased risk of infection due to the tubing set requiring to be replaced, there was no patient harm caused by the event.
Additional Manufacturer Narrative
The customer¿s report that the tubing set separated and leaked below the filter was confirmed.Visual inspection observed that the set was separated at the junction of the vinyl tubing.It was noted upon receipt that the filter outlet pivot was broken off at the micron filter outlet port.Closer inspection under magnification observed stress marks at the break site.Functional testing was not performed due to the obvious breakage.The cause of the separation and leak was the condition of the set being broken into two halves at the junction of the tubing to the filter outlet.The root cause of the breakage was not determined.
Event or Problem Description
The customer reported that the pediatric department experienced a large bore iv tubing set that separated and leaked below the filter during patient use.The tubing set was replaced with a new set.Other than the increased risk of infection due to the tubing set requiring to be replaced, there was no patient harm caused by the event.

• 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: 8360495
• Report Number: 9616066-2019-00423
• Device Sequence Number: 2254161
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: 10885403463969
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 2232-0007
• Device Catalogue Number: 2232-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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: 8100,8015, THERAPY DATE (B)(6) 2019