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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-LEGACY® PCA PUMP; PUMP, INFUSION, PCA

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SMITHS MEDICAL ASD, INC. CADD-LEGACY® PCA PUMP; PUMP, INFUSION, PCA Back to Search Results
Catalog Number 21-6300-02
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Overdose (1988)
Event Date 10/07/2016
Event Type  Injury  
Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.(b)(4).
 
Event Description
It was reported that a cadd-legacy pca pump was involved in an oxynorm overinfusion incident.The infusion was programmed for 6 days but was observed that the cassette (100ml) was empty and infused into the patient after 48 hours.Troubleshooting involved testing the infusion system without patient involvement and showed that the system infused 3 times more than the programmed volume.The infusion system was tested with different cassettes and it was noted that the problem stopped.The cassette involved in the incident was retested without patient involvement and the observed incident did not occur again.Intravenous narcan was administered to decrease the oxynorm overinfusion effects.No permanent injury was reported.See mfr: 3012307300-2016-00360.
 
Manufacturer Narrative
One cadd-legacy® pca pump was returned for investigation.Visual inspection of the returned device found it to be in good condition.A review of the device event history log found that the device had delivered the volumes of medication as programmed by the clinician.Functional accuracy sensor testing were performed on the device.No discrepancies were found during testing and the device was found to be within specification for delivery accuracy and alarm sensors.Investigation did not find fault with the returned device and determined that it functioned as designed.
 
Event Description
It was further reported that the device was in use starting on (b)(6) 2016 and the reported event was observed on (b)(6) 2016.Additionally it was reported that the device was programmed at a rate of 0.1 ml/h with an allowed bolus rate of 0.25ml.
 
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Brand Name
CADD-LEGACY® PCA PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.
3350 granada avenue
oakdale MN 55128
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6103282
MDR Text Key59965909
Report Number3012307300-2016-00361
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/24/2016
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? Yes
Device Operator Health Professional
Device Catalogue Number21-6300-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/24/2016
Initial Date FDA Received11/15/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CADD¿ MEDICATION CASSETTE WITH FLOW STOP
Patient Outcome(s) Required Intervention;
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