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

Model Number	11609481
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient age/date of birth was requested but was not provided.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.
Event or Problem Description
The customer reported that while the rn was removing the tubing from the isolette the tubing separated while infusing tpn to a patient in the nicu.There was no harm.
Event or Problem Description
The customer reported that while the rn was removing the tubing from the isolette the tubing separated while infusing tpn to a patient in the nicu.There was no harm.
Additional Manufacturer Narrative
The customer¿s report the tubing separated was confirmed.Visual inspection confirmed that the set was separated at the engagement between the filter inlet and tubing.The root cause of the separation is due to insufficient solvent during the manufacturing process.

• 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: 8234447
• Report Number: 9616066-2019-00062
• Device Sequence Number: 1886938
• Product Code: FPA
• UDI-Device Identifier: 10885403232596
• UDI-Public: 10885403232596
• 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): 12/21/2018

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 Model Number: 11609481
• Device Catalogue Number: 11609481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1