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

Model Number 8120

Device Problems Inaccurate Delivery (2339); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Insufficiency (4462)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation 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.No devices received, log review only.

Event Description

It was reported that a pca infusion error occurred wherein a patient received about 5 mg of hydromorphone, which was confirmed through visual inspection by nursing staff.However per hospital pharmacist's review of infusion knowledge portal data, about only 0.6 to 1mg of the medication was delivered via pca syringe pump.Pca module was programmed as pca dose only and the total dose concentration of the medication was hydromorphone 30mg/30ml.There was patient involvement and the issue resulted in over sedation/respiratory depression.The patient received a reversal agent and recovered.

Event Description

It was reported that a pca infusion error occurred wherein a patient received about 5 mg of hydromorphone, which was confirmed through visual inspection by nursing staff.However per hospital pharmacist's review of infusion knowledge portal data, about only 0.6 to 1mg of the medication was delivered via pca syringe pump.Pca module was programmed as pca dose only and the total dose concentration of the medication was hydromorphone 30mg/30ml.There was patient involvement and the issue resulted in over sedation/respiratory depression.The patient received a reversal agent and recovered.

Event Description

It was reported that a pca infusion error occurred wherein a patient received about 5 mg of hydromorphone, which was confirmed through visual inspection by nursing staff.However per hospital pharmacist's review of infusion knowledge portal data, about only 0.6 to 1mg of the medication was delivered via pca syringe pump.Pca module was programmed as pca dose only and the total dose concentration of the medication was hydromorphone 30mg/30ml.There was patient involvement and the issue resulted in over sedation/respiratory depression.The patient received a reversal agent and recovered.

Event Description

It was reported that a pca infusion error occurred wherein a patient received about 5 mg of hydromorphone, which was confirmed through visual inspection by nursing staff.However per hospital pharmacist's review of infusion knowledge portal data, about only 0.6 to 1mg of the medication was delivered via pca syringe pump.Pca module was programmed as pca dose only and the total dose concentration of the medication was hydromorphone 30mg/30ml.There was patient involvement and the issue resulted in over sedation/respiratory depression.The patient received a reversal agent and recovered.

Manufacturer Narrative

Omit: a140504 - inaccurate delivery (2339), c20 - no findings available, b17 - device not returned.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: 12743402
• MDR Text Key: 279773842
• Report Number: 2016493-2021-68878
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: (01)10885403812002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1520-2017
• Patient Sequence Number: 1
• Treatment: 8015; 8100; 8210; 8300; 8015
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Male
• Patient Weight: 87 KG