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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number C24105E
Device Problem No Audible Alarm (1019)
Patient Problem Respiratory Distress (2045)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 100ml b braun ndc: (b)(4), lot j8j680, exp 10/2019, 5% dextrose injection; 1000ml b braun ref l6100, ndc: (b)(4), lot j8k031, exp 02/2021, 5% dextrose and 0. 9% nacl; non-bd secondary set, therapy date: (b)(6) 2018. The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported that the device allowed air bubbles through the air-in-line detector without alarming during a d5%ns infusion at 150ml/hr, and a secondary zofran 16mg infusion over 15 minutes. The air-in-line detection was set to 75 microliters and the accumulated air settings were enabled. Although there was no lasting injury, the patient experienced shortness of breath and the nurse practitioner was notified. The device was sequestered with the iv administration set disconnected. The biomed department tested the device on 12/21/2018 and found no discrepancies using the calibrated administration set and a calibrated dryset (asm check-in test). They also performed an air bubble detection test and no air was noted in the line. The customer would like second opinion regarding the administration set that was used on the patient because there were 2 lines connected to it, as well as the lvp unit.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, 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 Key8274213
MDR Text Key133989620
Report Number9616066-2019-00142
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC24105E
Device Catalogue NumberC24105E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 01/24/2019 Patient Sequence Number: 1
Treatment
8015,(2)8100,PRI TUBING, THERAPY DATE: (B)(6) 2018
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