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

Model Number	10013072
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that after a primary infusion of etoposide 110mg/5.5ml at a rate of 542ml/hr had completed, there was 70ml of chemotherapy remaining in the bag.The total volume was 545.2ml.The customer states that there was no patient injury or medical intervention required.
Additional Manufacturer Narrative
The customer complaint of under-infusion of etoposide could not be confirmed due to the product was not returned for failure investigation.A photo of an empty iv bag labeled with a volume of 545.2ml was provided by the customer.The root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that after a primary infusion of etoposide 110mg/5.5ml at a rate of 542ml/hr had completed, there was 70ml of chemotherapy remaining in the bag.The total volume was 545.2ml.The customer states that there was no patient injury or medical intervention required.

• 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: 8844259
• Report Number: 9616066-2019-02099
• Device Sequence Number: 18899293
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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
• Device Lot Number: 19048938
• 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: 07/30/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: 8015, 10013902, 8100, TD (B)(6) 2019