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

Model Number 8015

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Bradycardia (1751); Fetal Distress (1856); Therapeutic Response, Increased (2272); Increased Respiratory Rate (2486)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

The customers complaint of reported over infusion was confirmed during review of the device logs.Inspection: the pcu device s/n (b)(4) was received with the instrument seal broken.The right (male) iui was observed with damaged isolation ribs.No anomalies were observed with any of the electrical components.Log analysis results: no errors or malfunctions were recorded on the pcu or pca logs on the day of the customer complaint.The profile in use was ¿cfcv12-6-10 zzepidural ¿ the pcu was powered on (b)(6) 2020 at 8:34 am.At 8:35 am the source pca module was selected for programming, a bd 50ml syringe with a syringe volume of 45.97ml was read, a fentanyl/ropivacaine (drug id 1) was programmed as a pca and continuous infusion: with the following parameters: pca dose 5ml, continuous dose 12ml/h, max limit 22ml/1h and the infusion was started.At 8:35 am the pcu alarmed for battery discharge and the user connected the pcu to ac source to clear the alarm.At 8:39 am the pca module was restarted.Pvi at the time 0ml.At 8:44 am a pca dose request (5ml) was requested and delivered.Pvi after completed dose request 6.03ml.At 9:49 am the pca module was channeled off.Pvi at the time 18.33ml.The customer reported that the intended infusion program was to infuse 12ml over one hour, however during programming pca (5ml) + continuous (12ml/1hr) was selected.During the incident infusion a single pca dose of 5ml was requested and delivered as programmed.This resulted in an additional 5ml being delivered that was not reported by the customer.Review of the pca and pcu device logs observed no error or malfunctions on the reported incident date.On (b)(6) 2020 at 8:34 am the source pca module was programmed with a bd 50ml syringe with a volume of 45.97ml as a fentanyl/ropivacaine (drug id 1), pca and continuous infusion, pca dose 5ml, continuous dose 12ml/h, max limit 22ml/1h.One dose request was made and delivered during the programmed infusion and the infusion ran until it was channeled off at 9:49 am.Pvi at the time 18.33ml.Functional testing and asm testing of the returned pca module observed the module delivering fluid as intended.Internal inspection observed no anomalies with any of the electrical or mechanical components of both returned devices.Root cause: the root cause of the customer report of an overinfusion was determined to be due to user programming.Device history review: a review of the device history record showed the device had a manufacture date of 09/25/2017.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record in trackwise and sap was performed for the (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported from labor and delivery that during labor the delivering mother received a fentanyl epidural of 24 ml over one hour instead of the intended 12ml.The medications infusing were fentanyl 6mcg/ml and ropivacaine.25%in 50ml normal saline syringe.This resulted in a serious injury.The infant experienced decelerations in fetal heart rate."infant delivered approx.15 hours after concern with the infusion pump." the infant scored a 6/8 apgar score, developed transient tachypnea of the newborn (ttn) and was transferred to neonatal intensive care unit.The infant did well after treatment and was discharged at day 5.

• Brand Name: ALARIS PC UNIT
• 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: shari lynn groth ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11356601
• MDR Text Key: 232841280
• Report Number: 2016493-2021-25259
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• 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: company representative,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• 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
• Patient Outcome(s): Required Intervention