Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYRINGE PUMP; PUMP, INFUSION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION SD ALARIS SYRINGE PUMP; PUMP, INFUSION Back to Search Results
Model Number 8110
Device Problem Inaccurate Delivery (2339)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
The products have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
It was reported that during a bedside shift report, the volume in the fentanyl syringe was 14.6ml instead of the reported 13.88ml.After the morning cares were provided, the syringe volume discrepancy was noted again; the syringe pump displayed that there was 17.8ml in the syringe while it was very clear that the volume was less than that (13.56ml).The event occurred in neonatal intensive care unit (nicu).It was then noted that the issue resulted to an unspecified adverse event.No further information was provided.
 
Manufacturer Narrative
Investigation conclusion: the customer¿s stated issue of syringe pump volume discrepancy was not confirmed through a review of the device logs or through testing.The incident administration set and disposable syringe were not provided by the customer for investigation therefore could not be tested for this investigation.The log review found no programming errors that would explain a report of syringe pump volume discrepancy.An infusion of drug id 102 (fentanyl continuous) was started on (b)(6) 2020 at 1:14:46 pm and continued through (b)(6) 2020 until being channeled off at 10:16:58 am.The compared volumes described in the complaint were not confirmed in the logs to identify if an issue was present.Functional testing consisting of accuracy testing and disposable syringe loading performed on the source syringe module found the device operating in specification when a disposable was properly loaded.Device inspection: an internal and external inspection were performed on the source device.There were no observations of fluid ingress in the front cover or rear case.There was no contamination observed on the electronic or mechanical components.The male iui has damaged isolation ribs.The female iui appears to have dried fluid on all pins.Root cause analysis: the root cause of the customer¿s complaint was not definitively identified in this investigation.The syringe module demonstrated to be in specification for accuracy and operating as intended when the unit is loaded and selected with the correct syringe.Device history review: review of the s/n (b)(6) service history record showed the device had a manufacture date of 09jul2018.A review of the device service history record was performed beginning from the date of manufacture to the present date 28oct2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.
 
Event Description
It was reported that during a bedside shift report, the volume in the fentanyl syringe was 14.6ml instead of the reported 13.88ml.After the morning cares were provided, the syringe volume discrepancy was noted again; the syringe pump displayed that there was 17.8ml in the syringe while it was very clear that the volume was less than that (13.56ml).The event occurred in neonatal intensive care unit (nicu).It was then noted that the issue resulted to an unspecified adverse event.No further information was provided.
 
Manufacturer Narrative
Additional information was provided by the customer.
 
Event Description
It was reported that during a bedside shift report, the volume in the fentanyl syringe was 14.6ml instead of the reported 13.88ml.After the morning cares were provided, the syringe volume discrepancy was noted again; the syringe pump displayed that there was 17.8ml in the syringe while it was very clear that the volume was less than that (13.56ml).The event occurred in neonatal intensive care unit (nicu).Additionally, it was reported that the infant was already in the icu setting and additional treatment was not required.No additional interventions were required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS SYRINGE PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10697923
MDR Text Key211917719
Report Number2016493-2020-19397
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8110
Device Catalogue Number8110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Date Manufacturer Received10/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015,; SYR TUBE, 8110, TD (B)(6) 2020; SYR TUBE, 8110, TD (B)(6) 2020
Patient Outcome(s) Required Intervention;
Patient Age6 MO
Patient Weight6
-
-