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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 2420-0007
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Venipuncture (2129); Therapeutic Response, Increased (2272)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative
The customer¿s report of an overinfusion of argatroban was confirmed. Unregulated flow was observed on the returned primary administration set (model 2420-0007). The event disposable was evaluated and found to be out of specification. Rate accuracy testing performed shows the non-concentricity (between inside diameter (id) and outside diameter (od) to have a direct impact on the rate accuracy performance. The root cause of the overinfusion of argatroban was an out of specification silicone tubing of the pumping segment of the event primary administration set.
 
Event Description
It was reported that the primary infusion of argatroban 50mg/50ml (glass bottle) infusing at a rate of 8. 4ml/hour, infused faster than expected and was completed within one hour of initiation on an adult patient. The devices were sequestered and found to be operating appropriately, and the programming by the end user was verified to be correctly entered. The patient experienced a higher than expected ptt/inr lab values and required additional lab work and monitoring, however there was no lasting harm to the patient from the event.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8652172
MDR Text Key146467792
Report Number9616066-2019-01505
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2019
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: 05/29/2019 Patient Sequence Number: 1
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