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

Model Number	C70101
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that a chemical spill occurred during setup as the vent cap assembly was missing from the tubing.While preparing nab-paclitaxel which is cytotoxic (a chemotherapy medication).As per instructions from (b)(6), the pharmacist primed the tubing with normal saline, attach the tubing to an empty viaflex bag, then added the nabpaclitaxel to the bag.When the line was primed the bag was hanging so they didn¿t notice the vent cap was missing.It wasn¿t until the nabpaclitaxel was added that fluid started leaking from the tubing.This happened in the biological safety cabinet.This was treated as a chemical spill and cleaned it up with no issue.There was no patient involvement.

• 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: 9577783
• Report Number: 9616066-2020-00008
• Device Sequence Number: 2901960
• Product Code: FPA
• UDI-Device Identifier: 10885403235733
• UDI-Public: 10885403235733
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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: 08/30/2021
• Device Model Number: C70101
• Device Catalogue Number: C70101
• Device Lot Number: 18085350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1