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

Model Number	2430-0500
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report of the tubing set had a hole located in the silicone segment was confirmed.Visual inspection of the set observed a small tear in the set¿s silicone segment tubing in which the tear was observed just below the set¿s upper fitment.A small gouge/crush mark was observed on the set¿s upper fitment just above the tear in the tubing.Functional testing observed leaking at the location of the tear.The root cause of the small tear in the silicone segment tubing was not definitively determined.
Event or Problem Description
It was reported that the tubing set had a hole located in the silicone segment.
Additional Manufacturer Narrative
The customer¿s report of the tubing set had a hole located in the silicone segment was confirmed.During visual inspection under a microscope it was observed that there was a small tear in the set¿s silicone segment tubing, just below the set¿s upper fitment.During functional testing drops of blue-dyed water were observed to be leaking out of the location of the tear.Pressure testing confirmed the leak.The root cause of the hole in the silicone segment tubing was not definitively determined.
Event or Problem Description
It was reported that the tubing set had a hole and leaked from the silicone segment in preparation for a rhma golimumab infusion that occurred prior to being connected to the patient the medication was remade and administered without complications.The customer later stated that there were no adverse effects caused to the patient from 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: 8891286
• Report Number: 9616066-2019-02291
• Device Sequence Number: 2683377
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/24/2019

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 Expiration Date: 05/27/2022
• Device Model Number: 2430-0500
• Device Catalogue Number: 2430-0500
• Device Lot Number: 19056843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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, TD (B)(6) 2019