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

Model Number 2426-0007

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the tubing ballooned at pumping segment.The bedside rn reported that an iv cellcept was hung on a transplant patient and within one minute the pump alarmed that the line was occluded.The nurse tried to troubleshoot the issue but the error kept occurring.The nurse then removed the tubing and noticed an abnormal bubbling of the tubing right below the blue plastic piece on the iv tubing that sits on top of the channel.At this point, the nurse called the charge rn to assess.The medication had to be wasted and new tubing and medication hung.There was no patient harm.

Manufacturer Narrative

Additional information added to: d4, & h4.The customer report of balloon in the silicone segment was confirmed per photo received by the customer.Photo shows a bulge/balloon in the silicone segment tubing near the upper fitment.Previous 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.No product will be returned per customer.

Event Description

It was reported that the tubing "ballooned" at the pumping segment.The bedside rn reported that an iv cellcept was hung on a transplant patient and within one minute, the pump alarmed that the line was occluded.The rn tried to troubleshoot the issue but the error kept occurring.The rn then removed the tubing and noticed an abnormal "bubbling" of the tubing right below the blue plastic piece on the iv tubing that sits on top of the channel.At this point, the rn called the charge rn to assess.The medication had to be wasted and new tubing and medication hung.Although requested, there is no further patient or event information available.

• 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: 9359171
• MDR Text Key: 194143389
• Report Number: 9616066-2019-03339
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19075219
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2019