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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL CADD SOLIS AMBULATORY INFUSION PUMP; MEA - PUMP, INFUSION, PCA
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SMITHS MEDICAL CADD SOLIS AMBULATORY INFUSION PUMP; MEA - PUMP, INFUSION, PCA Back to Search Results
Model Number 21-2111
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Overdose (1988); Decreased Respiratory Rate (2485)
Event Date 11/05/2014
Event Type  Injury  
Event Description
A report was received stating that while nurse was setting up the pump on a patient for the administration of fentanyl, the patient received an over-infusion of medication.The report stated that the nurse pressed the prime button to prime the line.She took her finger off the pump button and presumed that the pump would stop much like the pumps she had been familiar with in the past.The nurse connected the pump line to the patient and carried on with her other duties, neglecting to select the "stop priming" button so the pump delivered the standard 10 mls of medication before stopping automatically.The 10 ml infusion of fentanyl was delivered to the patient in a short amount of time.As a result, the patient went into respiratory arrest.The patient was given a dose of naloxone and recovered respiratory function.Patient was monitored and transferred to the appropriate ward once clinician was satisfied with vital signs.Patient recovered well after the event.
 
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
 
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Brand Name
CADD SOLIS AMBULATORY INFUSION PUMP
Type of Device
MEA - PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4344843
MDR Text Key5137767
Report Number2183502-2014-00983
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K072144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number21-2111
Device Catalogue Number21-2111-0100-50
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2014
Distributor Facility Aware Date11/05/2014
Event Location Hospital
Initial Date Manufacturer Received 11/11/2014
Initial Date FDA Received12/11/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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