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

Model Number 8100

Device Problems Free or Unrestricted Flow (2945); Insufficient Information (3190)

Patient Problem Fetal Distress (1856)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.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.H3 other text : device was not returned to manufacturing facility.

Event Description

It was reported that when the pump was opened, the safety clamp did not engage.This resulted into pitocin infusing; patient reportedly was in labor, causing an 8-minute fetal deceleration.Although requested, additional information was not known by the customer.Devices were not available for return.

Event Description

It was reported that when the pump was opened, the safety clamp did not engage.This resulted into pitocin infusing; patient reportedly was in labor, causing an 8-minute fetal deceleration.Although requested, additional information was not known by the customer.Devices were not available for return.

• Brand Name: ALARIS SYSTEM
• 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: 16972799
• MDR Text Key: 315650380
• Report Number: 2016493-2023-168069
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

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 ALARIS LVP MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention