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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)

Patient Problems Apnea (1720); Hypoxia (1918); Oversedation (1990)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.The medwatch report was reviewed and did not list any information with regards to the initial reporter's contact information (entity, phone number, email address), or the location the event occurred.Unable to obtain additional information or product return as the customer contact details/customer entity remains unknown, and no hospital name, address, or contact person's phone or e-mail is provided.

Event Description

Received a copy of the customer's sus voluntary event report (mw5099919) from fda which states, ¿a patient was taken to the operating room for a planned hemorrhoidectomy under sedation.He had received 2mg versed prior to transport.He moved himself to the prone position on the operating room bed.Monitors, nasal cannula oxygen and a propofol infusion were connected.The infusion was programmed to run at 35mcg/kg/min.While positioning was continuing, the patient became unresponsive and spo2 dropped.It was then noted that the 50ml propofol bottle was empty and that the patient had received an excess dose of propofol leading to apnea.Pump used: alaris smart pump.Investigation: pump was programmed and loaded correctly by the user, no obvious reason apparent for why fluid would free flow." the patient status is unknown.The medwatch report was reviewed and did not list any information with regards to the initial reporter's contact information (entity, phone number, email address), or the location the event occurred.Unable to obtain additional information or product return as the customer contact details/customer entity remains unknown, and no hospital name, address, or contact person's phone or e-mail is provided.

• 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: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11735515
• MDR Text Key: 247676632
• Report Number: 2016493-2021-503763
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No
• 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: 8015; PRI TUBING
• Patient Outcome(s): Required Intervention