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

Model Number 8100

Device Problems Fail-Safe Problem (2936); Free or Unrestricted Flow (2945)

Patient Problem No Code Available (3191)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.All available information has been provided.Patient identifier, race, and ethnicity were requested but not provided.

Event Description

It was reported that a primary infusion of insulin was found to be empty a few minutes after removing the tubing from the pump module and moving the patient for transport.The free flow was not witnessed but determined to be a free flow event due the bag being empty prematurely.It is estimated that 40 units/40ml of insulin free flowed into the patient who had an admitting diagnosis of diabetic ketoacidosis (dka).The "low sorb" tubing had been in use for hours.The patient required frequent blood glucose checks, the insulin infusion stopped, and dextrose (d5) fluids started.

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.All available information has been provided.Patient identifier, race, and ethnicity were requested but not provided.

Event Description

It was reported that a primary infusion of insulin was found to be empty a few minutes after removing the tubing from the pump module and moving the patient for transport.The free flow was not witnessed but determined to be a free flow event due the bag being empty prematurely.It is estimated that 40 units/40ml of insulin free flowed into the patient who had an admitting diagnosis of diabetic ketoacidosis (dka).The "low sorb" tubing had been in use for hours.The patient required frequent blood glucose checks, the insulin infusion stopped, and dextrose (d5) fluids started.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9802791
• MDR Text Key: 182472926
• Report Number: 2016493-2020-00288
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOW SORB PRIMARY TUBING, 8015, TD 9/3/19; LOW SORB PRIMARY TUBING,8015, TD (B)(6) 2019
• Patient Outcome(s): Other
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 25 KG