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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD-LEGACY PCA AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA
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NULL CADD-LEGACY PCA AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 6300
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation - the testing of the returned device showed the delivery accuracy results were slightly above the system specifications (+/-6%).Three delivery tests were performed and the first test showed the device delivered at +6.68% over nominal.The device expulsor was replaced to address this issue.
 
Event Description
It was reported that the device "failed flow rate".No known adverse effects to patient.
 
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Brand Name
CADD-LEGACY PCA AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section G)
NULL
Manufacturer Contact
david halverson
6000 nathan lane north
6720 bertner ave
minneapolis, MN 55442
MDR Report Key8142692
MDR Text Key129761511
Report Number3012307300-2018-05004
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586019449
UDI-Public10610586019449
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982839
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/07/2018
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 Model Number6300
Device Catalogue Number21-6300-51
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/08/2018
Initial Date FDA Received12/07/2018
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 N
Patient Sequence Number1
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