MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR

Model Number	C20025
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: optia apheresis device; vortex implantable port; apheresis tubing set; large bore needle.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that they work in conjunction with the (b)(6) in providing apheresis therapy to their patients and that they are currently in the process of certifying their own apheresis unit.The customer reported that the optia device that performs apheresis treatment alarmed for "air detected in centrifuge" while using the extension tubing set.It was found that the extension tubing set pulled air from the outside into the apheresis kit and caused the kit/plasma exchange to malfunction leaving the nurse with the option of either performing a rinseback or to discontinue the apheresis therapy.Instead, the nurse replaced the extension tubing set to a different product and the issue was resolved.There was no patient harm.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8368804
• Report Number: 9616066-2019-00485
• Device Sequence Number: 1833477
• Product Code: FPA
• UDI-Device Identifier: 10885403235504
• UDI-Public: 10885403235504
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: 12/07/2021
• Device Model Number: C20025
• Device Catalogue Number: C20025
• Device Lot Number: 18125449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1