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

Model Number	C25012
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
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 extension set does not connect correctly to the closed system drug transfer device (cstd) phaseal optima.It was then noted that disconnections and leaks have occurred while infusing chemotherapy blinatumomab.Phaseal optima was removed from the tubing set-up and infusion was continued.There was no patient harm.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that extension set does not connect correctly to the closed system drug transfer device (cstd) phaseal optima.It was then noted that disconnections and leaks have occurred while infusing chemotherapy blinatumomab.Phaseal optima was removed from the tubing set-up and infusion was continued with no further issues.There was no patient harm and there was no harm to healthcare provider.

• 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: 9565156
• Report Number: 9616066-2020-00068
• Device Sequence Number: 2224729
• Product Code: FPA
• UDI-Device Identifier: 10885403235610
• UDI-Public: 10885403235610
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 12/13/2021
• Device Model Number: C25012
• Device Catalogue Number: C25012
• Device Lot Number: 18125706
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/05/2020
• 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: BD PHASEAL OPTIMA SYSTEM,PRI TUBING, TD UNK
• Patient Age: 32 YR
• Patient Weight: 91