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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL, ASD, INC. CADD® CADD-LEGACY® PCA PUMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 1400
Device Problems Use of Incorrect Control/Treatment Settings (1126); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during use of a cadd® cadd-legacy® pca pump, an extra dose was given in the morning instead of the morning dose.The morning dose was eventually given by accident at 5:00 pm.The outcome of the event was resolved.No adverse events were reported.
 
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Brand Name
CADD® CADD-LEGACY® PCA PUMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
1265 gray fox road
st. paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7105912
MDR Text Key94665949
Report Number3012307300-2017-02529
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1400
Device Catalogue Number21-1400-06
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/29/2017
Initial Date FDA Received12/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age60 YR
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