MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,EXTENSSION,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.(b)(4).The customer report that the extension tubing set pulled air was not confirmed.Visual inspection of the set showed dried blood residue around the area of the luer exit and specks of dried blood residue on both luer caps.Functional testing showed no anomalies.The root cause of the customer's report was not identified.The mating components used during the reported event were not received for investigation.
Event or Problem Description
The customer reported that they work in conjunction with the american red cross - western blood services division 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 discontinuing 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,EXTENSSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8387743
• Report Number: 9616066-2019-00486
• Device Sequence Number: 1795645
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1