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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 2426-0007
Device Problems Leak/Splash (1354); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)
Patient Problems Eye Injury (1845); Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Manufacturer Narrative
No product will be returned per customer. The customer complaint could not be confirmed because the product was not sequestered for failure investigation. The root cause of this failure was not identified. The customer was not using a primary set that was rated for pressure injections (such as ct contrast). The customer was not using a primary set that was rated for pressure injections (such as ct contrast).
 
Event Description
It was reported by radiology technicians that during ct scan procedures using power injection, they experienced obstruction of flow and/or split tubing at the most distal port of the line. The tubing was attached to the ct medrad power injector for injection of contrast media (omnipaque 300). In one particular event, the split tubing resulted in contrast "shooting" into the patient's eye. A hot compress was used to treat the eye, however no further information regarding the patient was provided. The ct technicians implemented a 'work around' by accessing the iv directly instead of piggy-backing the contrast into the primary line. The reported that this additional step delayed the procedures and introduced an unnecessary compromise to the sterile set.
 
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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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8948509
MDR Text Key156338527
Report Number9616066-2019-02410
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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: 08/30/2019 Patient Sequence Number: 1
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