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

Model Number 2426-0007

Device Problems Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reported that during the day shift when giving a bolus through the pump after a heparin infusion, the machine displayed ¿channel error¿.The patients iv tubing was kinked, massaged to seemingly continue the flow, but the pump was still showing ¿channel error¿.When opening the channel there was a bubble at the top of the tubing.When the tubing was removed, it separated from the blue connection and splashed in the nurse's eye and face.There was no lasting harm.

Event Description

The customer reported that during the day shift when giving a bolus through the pump after a heparin infusion, the machine displayed ¿channel error¿.The patients iv tubing was kinked, massaged to seemingly continue the flow, but the pump was still showing ¿channel error¿.When opening the channel there was a bubble at the top of the tubing.When the tubing was removed, it separated from the blue connection and splashed in the nurse's eye and face.There was no lasting harm.

Manufacturer Narrative

Two of the customer's reported issues were confirmed.Inspection of the set showed a separation at the engagement between the upper fitment and silicone segment components.The silicone segment was slightly pressed and it was observed that the area directly below the upper fitment was more pliable when compared to the rest of the silicone segment.Visual inspection of the separated silicone segment showed no obvious bulging, kinks, damage, or other issues.Pressure testing replicated a bulge in the silicone.The customer's report that the tubing kinked was not confirmed.The root cause was not identified.The customer's report that the tubing ballooned at the pumping segment was confirmed.The balloon was caused by excessive pressure within the silicone segment which caused the silicone segment to balloon/bulge.The root cause for the source of the excessive pressure is unknown.The customer's report that the tubing leaked was confirmed.The leak was due to the observed set separation.The root cause of the separation was not identified.

• 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: 8182863
• MDR Text Key: 131332608
• Report Number: 9616066-2018-02565
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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 Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100,TD UNK