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

Model Number	11607704
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Insufficient Device Problem Information (3190); Application Program Problem: Medication Error (3198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: propofol bottle; td unk.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.Patient demographics requested however not provided.
Event or Problem Description
It was reported that propofol was infusing at an unspecified rate however 45 mins later the rn noticed that half the bottle of propofol was administered.The rn turned the device off and restarted with not further issues.The event occurred in the micu.
Event or Problem Description
It was reported that propofol was infusing at an unspecified rate however 45 mins later the rn noticed that half the bottle of propofol was administered.The rn turned the device off and restarted with not further issues.The event occurred in the micu.It was later reported "this turned out not to be an issue at all after investigating, as it was determined to be a miscalculation".
Additional Manufacturer Narrative
Additional info: per customer this event was due to a miscalculation.

• 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: 8770545
• Report Number: 9616066-2019-01886
• Device Sequence Number: 1689651
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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 Expiration Date: 05/08/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19055609
• 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: 07/09/2019
• Supplement Report FDA Received Date: 08/02/2019
• 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, TD UNK; 8100,8015, TD UNK