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

Model Number	C25004E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
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 a propofol infusion leaked while in the mri suite of radiology for a procedure.The icu patient was transported to radiology with a long and short extension set primed with propofol at an unspecified rate for sedation, while the infusion devices remained outside the mri.Within 1 hour of attaching the extension sets, the patient became increasingly agitated while on the mri table , and the user noticed a large wet area on the sheets leaking propofol.The patient required an additional dose of sedative (propofol ) to prevent the patient from removing the endotracheal tube.Although requested, no further details were provided by the customer for this event.
Event or Problem Description
It was reported that a propofol infusion leaked while in the mri suite of radiology for a procedure.The icu patient was transported to radiology with a long and short extension set primed with propofol at an unspecified rate for sedation, while the infusion devices remained outside the mri.Within 1 hour of attaching the extension sets, the patient became increasingly agitated while on the mri table , and the user noticed a large wet area on the sheets leaking propofol.The patient required an additional dose of sedative (propofol ) to prevent the patient from removing the endotracheal tube.Although requested, no further details were provided by the customer for this event.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8412879
• Report Number: 9616066-2019-00662
• Device Sequence Number: 18899377
• Product Code: FPA
• UDI-Device Identifier: 10885403235580
• UDI-Public: 10885403235580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C25004E
• Device Catalogue Number: C25004E
• 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: 03/12/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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: 8100,8015,10012144,30262E, TD (B)(6) 2019.; 8100,8015,10012144,30262E, TD (B)(6) 2019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR