• 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 8120 ALARIS PCA; 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 8120 ALARIS PCA; PUMP, INFUSION Back to Search Results
Model Number 8120
Device Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
The customer¿s experience of syringe volume discrepancies was not confirmed.Only the pca logs and customer dataset were received for investigation.The pca module event log shows the last infusion was programmed at 12:41 pm on 02 may 2018 for pca s/n (b)(4), to infuse a continuous infusion at 1.2ml/hr with a vtbi of 9.9562ml using a 35ml monoject syringe with 10.1312ml detected and ran until 12:42 pm when the infusion was paused and then channeled off.A determination regarding syringe volume discrepancies cannot be made based on the information provided.A review of the device history record in sap for sn (b)(4) was performed which confirmed that this device was not involved in a production failure and product was returned for the servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was patient involvement.
 
Event Description
The customer is requesting assistance in determining the root cause for volume discrepancies found when infusing hydromorphone 1mg/ml with a demand dose of 0.2mg every 10 minutes through the pca channel.Users have found a discrepancy between the remaining volume to be infused and the expected volume.There was no patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
8120 ALARIS PCA
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
prabhu somu
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10815820
MDR Text Key226357086
Report Number2016493-2020-36552
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10885403812002
UDI-Public10885403812002
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8120
Device Catalogue Number8120
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age65 YR
-
-