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

Model Number	11607704
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: (3) extension tubing sets; pressure transducer; 2 stopcocks; td (b)(6) 2019.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.Patient is an infant.Although requested, additional patient information was not provided.
Event or Problem Description
It was reported that the iv tubing set separated at the slide clamp.There was no consequence or impact to the patient.No further information was provided.
Event or Problem Description
It was reported that the iv tubing set separated at the safety clamp below the pump segment.There was no consequence or impact to the patient.No further information was provided.
Additional Manufacturer Narrative
The customer's report that the tubing set separated at the lower fitment was confirmed based on the separation at the engagement between the tubing and the lower fitment.Further inspection of the separated tubing end identified the issue to be due to insufficient solvent being applied at the tubing engagement.Dimensional measurement confirmed the tubing to be within specification.The root cause of the separation is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.

• 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: 10151499
• Report Number: 9616066-2020-01873
• Device Sequence Number: 2850668
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 11607704
• Device Catalogue Number: 11607704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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: 10ML BD SYRINGE, TD 12/13/2019