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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 2420-0500
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem Hypoglycemia (1912)
Event Date 11/03/2017
Event Type  Injury  
Manufacturer Narrative
The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
The crack and leak were at the smartsite. The patient¿s glucose level was greater than 100 prior to the event and dropped to less than 70. The event occurred in critical care.
 
Manufacturer Narrative
The customer¿s report that the tubing was cracked at the smartsite was not confirmed; the report of leaking at the smartsite was confirmed. Visual inspection showed no discernable damages. Microscopic inspection showed fluid movement between the outer wall of the tubing and the inner wall of the smartsite¿s tubing attachment area, indicating a solvent channel related to insufficient application of solvent during the manufacturing process. Functional and pressure testing confirmed leaking from the engagement between the standard bore tubing and the inlet port of the distal smartsite. Dimensional analysis results were within specification. The root cause of the insufficient/lack of solvent is attributed to improper assembly due to equipment and/or operator error.
 
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that the tubing was cracked and leaking while infusing tpn. The nurse stated that the patient became hypoglycemic and received an unspecified amount of dextrose.
 
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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 Key7075946
MDR Text Key109660127
Report Number9616066-2017-01528
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/07/2020
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number17085694
Other Device ID Number7613203012430
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2017
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: 12/01/2017 Patient Sequence Number: 1
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