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

Model Number 2426-0007

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that the tubing is causing air in line alarms.The nurse stated that they have had several issues of air in line alarms on the pump when there is no visible air in the tubing, even after adequately priming the tubing with fluid.The issue s resolved when new tubing is used on the same pump.There was no patient harm.

Manufacturer Narrative

Correction: disregard file (reviewed file, revised file from reportable malfunction to not-reportable as there was no allegation that the nuisance air in line alarms impacted the delivery of medication or fluid to the patient, as well as no adverse effects were caused to the patient from the event.).

Event Description

It was reported that the tubing is causing air in line alarms.The nurse stated that they have had several issues of air in line alarms on the pump when there is no visible air in the tubing, even after adequately priming the tubing with fluid.The issue s resolved when new tubing is used on the same pump.There was no patient harm.

• 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: 9875303
• MDR Text Key: 188872460
• Report Number: 9616066-2020-01068
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19107188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, THERAPY DATE (B)(6) 2020