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

Model Number	11426964
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿the etoposide started infusing, and staff stayed with patient for a few minutes, then went to get patient a pair of (b)(6) 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." an incomplete date of event of (b)(6) 2018 was provided.

• 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: 8095311
• Report Number: 9616066-2018-02325
• Device Sequence Number: 11449380
• Product Code: FPA
• UDI-Device Identifier: 10885403232367
• UDI-Public: 10885403232367
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2018

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: 11426964
• Device Catalogue Number: 11426964
• 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: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR