MAUDE Adverse Event Report: CAREFUSION ET CO2 MODULE DISPOSABLE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE20

Model Number ET CO2 MODULE DISPOSABLE

Device Problems Display or Visual Feedback Problem (1184); Self-Activation or Keying (1557); Unexpected Shutdown (4019)

Patient Problem Pain (1994)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: (2)8120;8015;8300; 8100; (2) syringetubing; pri tubing; therapy date: (b)(6) 2018.The customer¿s report of occlusion alarms was not confirmed.No device or device logs were returned or expected to be returned, therefore no failure investigation could be performed.The customer sent a photo of the alaris pcu channel error message.An investigation cannot be performed using the attached photo alone.The root cause of the customer's experience was not identified.

Event Description

It was reported that the facility went live with pca modules on (b)(6) 2018; on that day, the nurse (super user) initiated an unspecified pca infusion without difficulty.The next day, as the nurse was moving the iv pole the pca shut off and a channel error code 511.2010 was noticed on the pcu.When the pca was turned back on and the iv pole was moved again, the same issue occurred.As the iv pole was moved the 3rd time, the pca turned off; however in all 3 instances when the pca turned off, the lvp continued to infuse.At this time the pca was replaced with a 2nd pca module, and as the iv pole was moved, the pca shut off and a channel error code 511.2010 again scrolled across the pcu.As a consequence, due to the lack of delivery of pain medication, the patient experienced an increase in pain level.The pca module was taken to the utility room and tested with a new pcu and there were no issues.Subsequent information provided by the customer 3rd party investigation stated that this was an etco2 related issue.

• Brand Name: ET CO2 MODULE DISPOSABLE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE20
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8480181
• MDR Text Key: 140873327
• Report Number: 9616066-2019-00862
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031741
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET CO2 MODULE DISPOSABLE
• Device Catalogue Number: ET CO2 MODULE DISPOSABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other