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

Model Number 11607704

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Insufficient Information (3190); Application Program Problem: Medication Error (3198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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 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".

Manufacturer Narrative

Additional info: per customer this event was due to a miscalculation.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8770545
• MDR Text Key: 150456680
• Report Number: 9616066-2019-01886
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD UNK; 8100,8015, TD UNK