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

Model Number 2420-0007

Device Problems Stretched (1601); Material Deformation (2976); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Lot not provided by customer stated: " unable to narrow this down to a particular lot number at this time.".

Event Description

It was reported that the device alarmed during an unspecified infusion, the user open the door and noticed a bulge in the silicone segment.Although requested there was no additional event details provided or patient impact.

Event Description

It was reported that the device alarmed during an unspecified infusion, the user opened the door and noticed a "bulge" in the silicone segment.Although requested, there was no additional event details provided or patient impact related to the event.

Manufacturer Narrative

Additional information added; h.6.(device code).No product will be returned.Photo provided by the customer shows a balloon/bulge in the silicone segment tubing near the upper fitment.Although the root cause could not be definitively determined, previous extensive failure investigations have found that ballooning can occur when an iv push medication or flush is executed below the pump without first clamping the tubing above the injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to balloon.The root cause for the source of the excessive pressure is unknown.

• 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: 9416210
• MDR Text Key: 188691060
• Report Number: 9616066-2019-03511
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100, THERAPY DATE: UNK.