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

Model Number	MS3500
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that tubing was hung on night shift for iv tylenol.The medication did not infuse, but it was discovered that the vent on the tubing had not been opened.The vent was opened and the medication still did not infuse.There was no patient harm.
Additional Manufacturer Narrative
The customer report that the medication did not infuse was confirmed by functional testing when the dfu were not followed during priming.Visual inspection showed no anomalies.The root cause of the customer's report was a failure to follow instructions.
Event or Problem Description
It was reported that tubing was hung on night shift for iv tylenol.The medication did not infuse, but it was discovered that the vent on the tubing had not been opened.The vent was opened and the medication still did not infuse.There was no patient harm.
Event or Problem Description
It was reported that tubing was hung on night shift for iv tylenol.The medication did not infuse, but it was discovered that the vent on the tubing had not been opened.The vent was opened and the medication still did not infuse.There was no patient harm.

• 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: 8934022
• Report Number: 9616066-2019-02406
• Device Sequence Number: 13562801
• Product Code: FPA
• UDI-Device Identifier: 10885403222603
• UDI-Public: 10885403222603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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,Followup
• Report Date (Section B): 08/01/2019

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: 05/03/2022
• Device Model Number: MS3500
• Device Catalogue Number: MS3500
• Device Lot Number: 19055194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 08/30/2019; 09/03/2019
• 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, PRI TUBING, TD (B)(6) 2019; 8100, 8015, PRI TUBING, TD (B)(6) 2019