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

Model Number 2420-0500

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Patient information was requested, but not provided.Concomitant medical products: non-bd extension set (red cap on male luer); 1000ml baxter bag lot y318204 exp mar21, 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.

Event Description

It was reported that 1000 ml normal saline iv was primed/started in the cath lab and administered via iv pump.During the procedure, the infusion was stopped on the pump.The iv tubing remained hooked up to patient with another iv y-ported to the tubing and infusing near the insertion site.When the case was finished, the normal saline iv was removed from the iv pump and noted to have significant bulging near the area where the tubing was secured in the iv pump.The balloon was not discovered until after the case had concluded.There was no patient harm reported.

Manufacturer Narrative

The customer¿s report that the set had significant bulging (balloon) in the tubing was confirmed by visual inspection of the as-received sample.The balloon was located below the upper fitment¿s outlet port of the pump segment.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing, or damage to the components.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.No other anomalies or evidence of damage were observed upon initial visual inspection.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 that 1000 ml (ns) normal saline iv was primed/started in the cath lab and administered via iv pump.During the procedure, the infusion was stopped on the pump.The iv tubing remained hooked up to the patient with another iv, y-ported to the tubing and infusing near the insertion site.When the case was finished, the (ns) iv was removed from the iv pump and noted to have significant "bulging" near the area where the tubing was secured in the iv pump.The "balloon/bulge" was not discovered until after the case had concluded.It was further confirmed during follow up, that there was no patient harm as a result of this event.

• 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: 9629906
• MDR Text Key: 198720229
• Report Number: 9616066-2020-00279
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1