MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

The customer¿s report of an over infusion incident involving the drug precedex was not confirmed or replicated during the investigation; however the incident disposable set was found to have an eccentric (out of round) condition.Visual inspection of the disposable iv set identified an eccentric condition.Physical inspection noted the pump module to be in good condition with no damage or anomalies observed.Review of the log shows no programming errors or any existing malfunctions that would indicate an over infusion had occurred.The returned infusion system had under infused with an error at -6% rate accuracy testing found the device to be within specification with no unregulated flow.The cause of the overinfusion was the eccentric (out of round) condition of the silicone segment, which has been identified to be a contributing factor to incidents of over infusion.

Event Description

It was reported that precedex (0.2 mcg/kg/hr) was initiated at 1015 at a rate of 3.5ml/hr, and 2 hours later reduced to 1.9ml/hr (0.1 mcg/kg/hr) due to the patient experiencing hypotension and bradycardia.By 1610, there was 5ml remaining in the bag, however the pump indicated a vtbi of 70ml.The initial vtbi was 85ml (15ml to prime the line).Two nurses double checked the infusion settings and pump, however no errors were found.The infusion was stopped; the line, medication and pump module were removed and the doctor was notified of the event.There was no patient harm reported.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8811935
• MDR Text Key: 151737229
• Report Number: 9616066-2019-01796
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8015,8100, THERAPY DATE (B)(6) 2019
• Patient Outcome(s): Required Intervention
• Patient Weight: 75