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

Model Number	11612593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/21/2020
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.
Event or Problem Description
It was reported that the tubing set separated at the engagement of the pump segment to the lower fitment and leaked while infusing total parenteral nutrition (tpn).No further information was provided.
Additional Manufacturer Narrative
Correction: d.4;g.5.
Event or Problem Description
It was reported that the tubing set separated at the engagement of the pump segment to the lower fitment and leaked while infusing total parenteral nutrition (tpn).No further information was provided.
Additional Manufacturer Narrative
The customer's report that the tubing set separated at the engagement of the pump segment to the lower fitment and leaked was confirmed based on visual inspection of the as-received set sample.The set was received separated at the engagement between the silicone segment and lower fitment of the pump chamber assembly.The expected retainer ring for this engagement was not received; however inspection of the separated silicone segment end observed evidence of a retainer ring indentation which does not look to be misaligned along the silicone segment tubing.Dimensional analysis of the available separated components observed they were within specification.No testing was deemed necessary due to the obvious separation.The root cause of the separation was not identified.
Event or Problem Description
It was reported that the tubing set separated at the engagement of the pump segment to the lower fitment and leaked while infusing total parenteral nutrition (tpn).No further information was provided.

• 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: 10064390
• Report Number: 9616066-2020-01671
• Device Sequence Number: 18999148
• 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: K894842
• 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,Followup
• Report Date (Section B): 04/27/2020

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: 11612593
• Device Catalogue Number: 11612593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/27/2020; 08/04/2020
• 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: 8015,8100, TD 04/21/2020; NON-BD MALE LUER, TD 04/21/2020; 8015,8100, TD: (B)(6) 2020