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 Low Blood Pressure/ Hypotension (1914)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

Patient demographics requested, however customer declined to provide.Patient was an adult.Concomitant medical products: 10ml bd syringe, lot: 9109619, exp: 2022-03, 0.9% sodium chloride.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.

Event Description

It was reported that in the icu a levophed infusion was titrated up for a patient's decreasing blood pressure.The nurse inspected the pump module and the tubing and discovered that the pumping segment had collapsed inside the channel resulting in an under-infusion of levophed.There were no device alarms noted.The tubing was changed and the levophed infusion resumed resulting in restoration of the patient's blood pressure.The customer states there was no injury or medical intervention.

Manufacturer Narrative

The customer report that the pumping segment had collapsed resulting in an underinfusion was not confirmed.The as-received samples were visually inspected for kinks, holes tears in the tubing or damages to the components.It was observed that a side of the silcone segment area, located directly underneath the upper fitment, was slightly indented inward.Functional testing showed no anomalies.The set was re-primed and no issues were observed.The root cause of the customer's report could not be determined.

Event Description

It was reported that in the icu a levophed infusion was increased for a patient's decreasing blood pressure.The rn inspected the pump module and the tubing, and discovered that the pumping segment had collapsed inside the channel resulting in an under-infusion of levophed.There were no device alarms noted.The tubing was changed and the levophed infusion resumed resulting in restoration of the patient's blood pressure.The customer states there was no injury or medical intervention 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: 9079222
• MDR Text Key: 160668185
• Report Number: 9616066-2019-02575
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• 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: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD: (B)(6) 2019.
• Patient Outcome(s): Other