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

Model Number	2430-0500
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was an infant.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 a possible over infusion occurred during an infusion, resulting in a transient elevation of the infant's blood glucose.The report also stated there was no harm to the patient as a result of the event.
Event or Problem Description
It was reported that a possible over infusion occurred during an infusion, resulting in a transient elevation of the infant's blood glucose.The report also stated there was no harm to the patient as a result of the event.Although requested, there was no additional information or details of the event provided.
Additional Manufacturer Narrative
The customer¿s report of a possible over infusion occurred was not confirmed.Visual inspection of the set noted the roller clamp in the open position and its slide clamp in the closed position.No other abnormalities were observed.Functional testing resulted in the sets silicone segments were rotated 90 degrees and then 180 degrees and reinserted into the pump module device with numerous run/pause tests performed.No over infusion was observed.Rate accuracy testing resulted in the primary set slightly under infusing fluids.Dimensional analysis performed found the silicone segment to be within specification.The root cause of the customer¿s report of a possible over infusion 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: 8691798
• Report Number: 9616066-2019-01616
• Device Sequence Number: 11176449
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2430-0500
• Device Catalogue Number: 2430-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other