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

Model Number 2426-0500

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 50ml baxter bag lot us005405 exp sep20, 0.9% sodium chloride injection.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Sections requested but not provided, however the customer stated that the patient was an adult.Additional patient information: diagnosis: stroke.

Event Description

It was reported by the neuroscience icu that after the rn hung the primary infusion of fentanyl the pump alarmed occlusion.The rn opened the device door and found that the tubing had a balloon in the silicone pumping segment.No adverse effects occurred to the patient.

Manufacturer Narrative

The customer¿s report that the iv tubing set ballooned in the pumping segment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed within the tubing from the drip chamber to the end of the male luer.During visual inspection of the set received it was noted that the silicone segment tubing had a balloon bulge at the top of the silicone pump segment tubing near the upper fitment.Further visual inspection of the inner diameter of the silicone tubing observed the tubing to be concentric.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported by the neuroscience icu that after the nurse hung the primary infusion of fentanyl, the pump alarmed occlusion.The nurse opened the device door and found that the tubing had a balloon in the silicone pumping segment.It was further confirmed during follow up that patient care was not delayed and that this event did not contribute to, or result in a serious adverse impact to patient.

• 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: 9795502
• MDR Text Key: 202429637
• Report Number: 9616066-2020-00676
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 7613203020992
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2020