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

Model Number 2420-0007

Device Problems Insufficient Flow or Under Infusion (2182); Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that during a trauma resuscitation an infusion of epinephrine was started when the clinician noticed the tubing was crimped just below the drip chamber causing a delay in treatment to the patient since the medication would not flow through the tubing and a replacement needed to be obtained from the supply room.There was no harm.

Event Description

The customer reported that during a trauma resuscitation an infusion of epinephrine was started when the clinician noticed the tubing was crimped just below the drip chamber causing a delay in treatment to the patient since the medication would not flow through the tubing and a replacement needed to be obtained from the supply room.There was no harm.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "spiked bag of medicine and charged drip chamber, fluid would not run through iv tubing, despite multiple manipulations.Tubing found to have severe crimp just below the drip chamber, usually able to open crimp by pinching tubing but was unable to get this particular one to function at all.Brief delay in getting epi drip started.".

Manufacturer Narrative

The customer¿s report of a tubing kink was confirmed.Visual inspection observed that the vinyl tubing was kinked from below the drip chamber outlet port.The kink was massaged out of the tubing, and the set was attached to a lab iv bag allowing fluid to flow through the set via gravity.No occlusions occurred during functional testing of the set.The same results occurred via infusion testing with a lab pump module.The packaging/coiling method was identified as the root cause of the kink tubing.

Manufacturer Narrative

Additional information provided from medwatch: 4900320000-2019-8008.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "spiked bag of medicine and charged drip chamber, fluid would not run through iv tubing, despite multiple manipulations.Tubing found to have severe crimp just below the drip chamber, usually able to open crimp by pinching tubing but was unable to get this particular one to function at all.Brief delay in getting epi drip started.".

• 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: 8388314
• MDR Text Key: 137811194
• Report Number: 9616066-2019-00653
• 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,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 65