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

Model Number	10013072
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint of a tubing leak could not be confirmed due to the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that during an infusion, an investigational medication was mixed in 100ml of normal saline and scheduled to be administered at a rate of 50 ml/hr.The infusion started at 15:30 and ended at 15:50, twenty minutes later.All inspections prior to the start of the administration did not detect any liquid leaking from the tubing, however; the nurse noticed a pool of liquid under the infusion pump and liquid dripping from the bottom of the pump.The pharmacist inspected the administration set and noted that the tubing connection to the iv was intact and that the tubing spike had not penetrated the iv bag neck.The remainder of the administration set appeared to be intact, except for the area around the infusion pump connection.This incident occurred in the ctu infusion suite of the cancer center.There was no patient impact.
Event or Problem Description
It was reported that during and infusion, an investigational medication was mixed in 100 ml of normal saline and scheduled to be administered at a rate of 50 ml/hr.The infusion started at 15:30 and ended at 15:50, twenty minutes later.All inspections prior to the start of the administration did not detect any liquid leaking from the tubing, however; the nurse noticed a pool of liquid under the infusion pump and liquid dripping from the bottom of the pump.The pharmacist inspected the administration set and noted that the tubing connection to the iv was intact and that the tubing spike had not penetrated the iv bag neck.The remainder of the administration set appeared to be intact, except for the area around the infusion pump connection.This incident occurred in the ctu infusion suite of the cancer center.There was no patient impact.
Additional Manufacturer Narrative
Bd aware date was (b)(6) 2019.

• 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: 9351021
• Report Number: 9616066-2019-03413
• Device Sequence Number: 19516476
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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 Model Number: 10013072
• Device Catalogue Number: 10013072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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: 8100,8015,THERAPY DATE (B)(6) 2019
• Patient Age: 74 YR