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

Model Number 2420-0007

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Therapeutic Response, Decreased (2271); Increased Respiratory Rate (2486)

Event Date 10/16/2018

Event Type  Injury  

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 15 minutes after the start of a nimbex infusion, the iv tubing was found to be cracked and leaking below the pump.The patient was unstable and was breathing above the ventilator due to the decrease in paralyzing agent.A new infusion was mixed and the tubing changed.No other effects to the patient were reported.

Manufacturer Narrative

The customer¿s report of cracked and leaking below the pump was confirmed.Functional priming testing observed a leak from the tubing approximately 36 inches above the distal smartsite port.Closer inspection of the leak under magnification observed a cut in the tubing.The root cause of the tubing leak is a small cut in the tubing.The root cause of the cut could not be identified.

Event Description

The customer reported that 15 minutes after the start of a nimbex infusion, the iv tubing was found to be cracked and leaking below the pump.The patient was unstable and was breathing above the ventilator due to the decrease in paralyzing agent.A new infusion was mixed and the tubing changed.No other effects to the patient were reported.

• 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: 8078983
• MDR Text Key: 127430292
• Report Number: 9616066-2018-02222
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, VENTILATOR, TD (B)(6) 2018; 8015,8100, VENTILATOR, TD (B)(6) 2018
• Patient Outcome(s): Other