MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS PUMP MODULE LOW SORBING INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	11426964
Health Effect - Clinical Code	Underdose (2542)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The etoposide started infusing, and staff stayed with patient for few minutes, then went to get patient a pair of johnny pants, came back and noticed that the chemo tubing had a slow leak/drip coming from module, so staff gowned, and gloved and stopped infusion immediately, opened two chemo spill kits, put on appropriate attire, disconnected patient from chemo tubing, used chemo spill kit to clean area of floor and disposed of anything that came into contact with the chemo into chemo bag.Unfortunately it was unknown how much chemo leaked to the floor and patient will resume chemo tomorrow at the scheduled time.

• Brand Name: ALARIS PUMP MODULE LOW SORBING INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7999090
• Report Number: 7999090
• Device Sequence Number: 428063
• Product Code: FPA
• UDI-Device Identifier: 50885403232365
• UDI-Public: (01)50885403232365
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018
• Report Date (Section F): 10/17/2018

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: No Information
• Device Model Number: 11426964
• Device Catalogue Number: 11426964
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/17/2018