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

Model Number 72213N

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/23/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Although requested, patient demographics not provided.

Event Description

It was reported that the pump was barely able to pull fluid through tubing.

Event Description

It was reported that the pump was barely able to pull a magnesium infusion through the secondary tubing set during an infusion on an adult patient.There was approximately 1 hour delay in administration of the infusion.There is no harm caused to the patient from the event.

Manufacturer Narrative

The customer¿s report of ¿barely able to pull a magnesium infusion through the secondary tubing set during an infusion¿ was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed on the set during visual inspection.Functional testing of priming and infusion testing did not replicate any occlusions or difficulties pulling fluid from the secondary set.The customer did not send in the primary set that the secondary was attached to during the time of this event.The root cause of the customer¿s report could not be identified.

• Brand Name: ALARIS® SECONDARY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8533398
• MDR Text Key: 142615571
• Report Number: 9616066-2019-01106
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: 72213N
• Device Catalogue Number: 72213N
• Device Lot Number: 19016280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2420-0500,8100,8015,TD (B)(6) 2019