MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2401-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
Received a copy of the customer's medwatch report from fda, which states ¿nursing changed lipid line infusing via a umbilical venous line and noted lipids leaking out of iv channel.Lipid iv line noted to be leading at a connector site.Iv tubing changed after new bag of lipids sent by pharmacy, causing a delay in lipid administration.There was no harm to the patient".An incomplete date of event of (b)(6) 2018 was provided.The customer later reports that the event occurred on (b)(6) 2018 and that there was a delay in lipid administration, but there was no resulting harm to the patient.
Event or Problem Description
Received a copy of the customer's medwatch report from fda, which states ¿nursing changed lipid line infusing via a umbilical venous line and noted lipids leaking out of iv channel.Lipid iv line noted to be leading at a connector site.Iv tubing changed after new bag of lipids sent by pharmacy, causing a delay in lipid administration.There was no harm to the patient." an incomplete date of event of xx-july-2018 was provided.The customer later reports that the event occurred on (b)(6) 2018 and that there was a delay in lipid administration, but there was no resulting harm to the patient.
Additional Manufacturer Narrative
The customer¿s report of a leak during a lipid infusion was confirmed.During inspection the tubing exterior was noted to be slippery to the touch.However, the reported leak was not reproduced during functional testing.The umbilical venous line was not provided for investigation, nor information describing any additional mated products.The root cause of the customer¿s report could not be determined.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7807270
• Report Number: 9616066-2018-01452
• Device Sequence Number: 1143478
• Product Code: FPA
• UDI-Device Identifier: 07613203012515
• UDI-Public: 7613203012515
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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 Model Number: 2401-0500
• Device Catalogue Number: 2401-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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: 8015, 8100, UMBILICAL VENOUS LINE, TD (B)(6) 2018
• Patient Weight: 1