MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Fail-Safe Problem (2936)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.Concomitant medical products: -(2) 2204-0007.Although requested, patient identifier, race, and ethnicity were not provided.

Event Description

It was reported that milrinone 200mcg/ml was intended to infuse at a rate of "3" but free flowed into a patient who was post-op from a heart transplant after the tubing was removed from the pump module and the roller clamp was not closed.The free flow was not witnessed but determined to be a free flow event due to the bag being empty prematurely.The patient was hypotensive and required multiple interventions to support their blood pressure, including vasopressin and phenylephrine.This event occurred in the cardiac icu, likely using the iicu 10-40k profile.

Manufacturer Narrative

Additional information added to: d4,d11,h4.The reported issue that the drug milrinone free flowed into a patient after the tubing was removed from the pump module could not be confirmed or replicated.Physical inspection of the suspect pump module confirmed the presence of a third party sear from an unknown supplier.Since log review only records events based on pump module programming and the reported issue was that a free-flow event occurred after the administration set was removed from the pump module, no conclusion could be drawn through log review.Per log review, the total volume recorded infused was.097 ml.Functional testing found that the pump module sear was able to properly close the safety clamp and that the pump module was not having any free flow events during door openings.The left leg of the sear was observed during inspection to be bent slightly upwards but testing of the door latch of the pump module found that the safety clamp was fully closing and opening as expected.Testing of the administration set roller clamp found it to be functioning as intended.Dimensional analysis of the silicone segment section found it to be within specifications.An incidental finding during initial rate accuracy testing was that the pump module was under infusing, which was corrected with recalibration in asm; this issue would not have been a contributing factor to the customer¿s reported incident.Carefusion has not tested nor validated the functionality of the pump, as a medical device and according to its specifications when used with products manufactured/refurbished and sold by third parties.The pump module safety clamp should be the secondary method for preventing free flow.The roller clamp should be the primary means of preventing free flow.The root cause of the reported issue that the drug milrinone free flowed into a patient after the tubing was removed from the pump module was not identified.

Event Description

It was reported that milrinone 40mg/200ml programmed at 200mcg/ml or was intended to infuse at a rate of "3" but free flowed into a patient who was post-op from a heart transplant after the tubing was removed from the pump module and the roller clamp was not closed.The free flow was not witnessed but determined to be a free flow event due to the bag being empty prematurely.The patient was hypotensive and required multiple interventions to support their blood pressure, including vasopressin and phenylephrine.This event occurred in the cardiac icu, likely using the iicu 10-40k profile.

• Brand Name: ALARIS® PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9807848
• MDR Text Key: 188208517
• Report Number: 2016493-2020-00292
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2)PRI TUBING,8015,(2)8100, TD (B)(6) 2020.; 8100, (2)2204-0007.
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 21