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

Model Number C25004E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Anxiety (2328)

Event Date 02/06/2019

Event Type  Injury  

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 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 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8412879
• MDR Text Key: 138552776
• Report Number: 9616066-2019-00662
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235580
• UDI-Public: 10885403235580
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C25004E
• Device Catalogue Number: C25004E
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015,10012144,30262E, TD (B)(6) 2019.; 8100,8015,10012144,30262E, TD (B)(6) 2019
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR