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

Model Number 8100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Extravasation (1842)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the failure investigation has been completed.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.

Event Description

It was reported an "extravasation" to the right antecubital fossa (acf) following the administration of potassium "premix" and normal saline.It was reported that the arm became "swollen" and that there was no alarm from the pump "to alert occlusion/pressure." it was reported that the clinician then discontinued the peripheral intravenous catheter and dressing was applied."tubigrip" (bandage) was reportedly applied to the swollen arm with cold pack and the extremity was raised using "gallow sling." later on, the tubigrip was reportedly removed and "crepe support bandage" was applied while keeping the gallow sling.It was reported that the neurovascular status was "intact." it was reported a "temporary" harm and "minor treatment" was required.Please note that alaris system is neither designed nor intended to detect infiltrations / extravasation and does not alarm under infiltration / extravasation conditions.Although the pump module has downstream occlusion detection, occlusion alarms do not detect or prevent infiltration.

Event Description

It was reported an "extravasation" to the right antecubital fossa (acf) following the administration of potassium "premix" and normal saline.It was reported that the arm became "swollen" and that there was no alarm from the pump "to alert occlusion/pressure." it was reported that the clinician then discontinued the peripheral intravenous catheter and dressing was applied."tubigrip" (bandage) was reportedly applied to the swollen arm with cold pack and the extremity was raised using "gallow sling." later on, the tubigrip was reportedly removed and "crepe support bandage" was applied while keeping the gallow sling.It was reported that the neurovascular status was "intact." it was reported a "temporary" harm and "minor treatment" was required.Please note that alaris system is neither designed nor intended to detect infiltrations / extravasation and does not alarm under infiltration / extravasation conditions.Although the pump module has downstream occlusion detection, occlusion alarms do not detect or prevent infiltration.

Manufacturer Narrative

Omit: b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available, a device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• 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: 16679590
• MDR Text Key: 312672556
• Report Number: 2016493-2023-140821
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2020
• 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
• Patient Outcome(s): Required Intervention