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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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CAREFUSION SD ALARIS SYSTEM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 8300
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Information (3190)
Patient Problem Lethargy (2560)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
It was reported that a patient was receiving pain medication (dilaudid) through patient controlled analgesia (pca) module and the infusion was programmed as "demand only" (pca only programming, not a continuous infusion).It was noted that the patient had been using only a small amount (4 doses delivered in 24 hours).Per order, the pca module was attached to an etco2 monitor, as part of the pca protocol.The etco2 monitor was connected to a nasal cannula with the sensor attached to the patient.However, the patient's husband, who was at the beside, reported that the "monitor was not registering." the patient was found to be lethargic and the staff called for rapid response team (rrt).The patient found to have "ph 6.97 and c02 of 118." there was patient involvement but no harm reported.
 
Manufacturer Narrative
Initial reporter addr 1: (b)(6).A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.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 product will be returned.
 
Event Description
It was reported that a patient was receiving pain medication (dilaudid) through patient controlled analgesia (pca) module and the infusion was programmed as "demand only" (pca only programming, not a continuous infusion).It was noted that the patient had been using only a small amount (4 doses delivered in 24 hours).Per order, the pca module was attached to an etco2 monitor, as part of the pca protocol.The etco2 monitor was connected to a nasal cannula with the sensor attached to the patient.However, the patient's husband, who was at the beside, reported that the "monitor was not registering." the patient was found to be lethargic and the staff called for rapid response team (rrt).The patient found to have "ph 6.97 and c02 of 118." there was patient involvement but no harm reported.
 
Manufacturer Narrative
Additional information : imdrf annex a, b, g codes and manufacturer narrative.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.
 
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Brand Name
ALARIS SYSTEM
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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 Key14050734
MDR Text Key294039051
Report Number2016493-2022-128869
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10885403830013
UDI-Public(01)10885403830013
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8300
Device Catalogue Number8300 ALARIS ETCO2 MODULE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
8015; 8120
Patient SexFemale
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