MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; INTEROPERABILITY

Catalog Number INTEROPERABILITY

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Bd technical support troubleshoot with customer over the phone.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device evaluated by bd.

Event Description

It was reported that the user tried to associate an electronic order on (b)(6) 2021 from 2245 to 2258 but was unsuccessful and instead, the pump was manually programmed at 2300.The user was not able to "prv" even after manual programming because on the i/o flowsheet it says order was in "groups that can't be documented on".The electronic order details that was sent to the device created a 9017 interoperability error.It was also noted a documentation issue on the electronic health record (ehr) epic side.There was patient involvement but no harm as user proceeded to use manual programming.

• Brand Name: ALARIS SYSTEM
• Type of Device: INTEROPERABILITY
• Manufacturer (Section D): 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: 12967266
• MDR Text Key: 281978153
• Report Number: 2016493-2021-76051
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: INTEROPERABILITY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• 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: 8015; 8100