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

Model Number	11059729
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.Addition information requested, but was not provided.
Event or Problem Description
It was reported that the medication was flowing faster than it should into the patient's iv tubing.Additional information was requested, but was not received.
Event or Problem Description
It was reported that the medication was flowing faster than it should into the patient's iv tubing.Additional information was requested, but was not received.
Additional Manufacturer Narrative
Additional information: d.11 no product will be returned per customer.The customer complaint of tubing and pump infusing medications too fast could not be confirmed due to the product was not returned for failure investigation.The root cause of this failure was not identified.

• 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: 9536266
• Report Number: 9616066-2019-03797
• Device Sequence Number: 11368550
• Product Code: FPA
• UDI-Device Identifier: 10885403232497
• UDI-Public: 10885403232497
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 11059729
• Device Catalogue Number: 11059729
• 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: 12/31/2019
• Supplement Report FDA Received Date: 04/01/2020
• 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, 8100