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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY; CADD LEGACY PUMP

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SMITHS MEDICAL CADD LEGACY; CADD LEGACY PUMP Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2017
Event Type  malfunction  
Event Description
Pump alarming while patient was using.No kinks no clamps.Sn (b)(4).Patient switched to back up pump with no interruption in treatment.No clinical or patient injury.Patient will return the non working pump back.Will send replacement.Dose or amount: veletri 17nkm.Frequency: 65ml/24h.Route: iv.Dates of use: (b)(6) 2017 to ongoing.Diagnosis or reason for use: pah.
 
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Brand Name
CADD LEGACY
Type of Device
CADD LEGACY PUMP
Manufacturer (Section D)
SMITHS MEDICAL
MDR Report Key6713950
MDR Text Key80175079
Report NumberMW5070989
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 07/10/2017
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 No Information
Device Expiration Date05/01/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/11/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age50 YR
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