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

Model Number	20038E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Venipuncture (2129)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: pca tube,pca syringe, cvl triple lumen, therapy date (b)(6) 2019.Patient demographics requested, however not provided by the customer.The event occurred in the pediatric bone marrow unit - therefore it is presumed the patient was a child.There was no report of lasting harm, and the all of the blood cultures were negative.The customer¿s report of leaks to two trifuse extension sets was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing, as well as infusion testing with a lab pump module and primary set at 75ml/hr did not produce a leak in any of the testing.Both extension sets male luer were dimensionally tested using male iso go/no go gauge and found to be within specification.The root cause of the customer¿s report was not identified.
Event or Problem Description
It was reported that on 2/17 at 6:30 pm, tpn, lipids and narcan infusions were initiated via pump module at an unspecified rate through the trifuse extension set.Also infusing at the time was a morphine pca syringe 1:1 infusion through a cvl (triple lumen catheter).At 11am the following day, the nurse noticed a leak at the trifuse extension set "at connection into pca." the line was changed and a new set up was started at 6:47 pm; however at approximately 8:00 pm, another leak was noticed at the trifuse.The entire set up was removed and replaced, and there were no further leaks or issues.As a result, the patient required blood cultures and unspecified replacement fluids due to the discontinuation of the tpn.There was no report of lasting harm and the all of the blood cultures were negative.Although requested no further details or information were provided from the customer.The event occurred in the pediatric icu bone marrow unit.

• 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: 8430406
• Report Number: 9616066-2019-00651
• Device Sequence Number: 193461
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: 7613203011976
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2019

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 Expiration Date: 11/13/2021
• Device Model Number: 20038E
• Device Catalogue Number: 20038E
• Device Lot Number: 18115997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention