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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES CURLIN PCA INFUSION PUMP; PUMP, PCA

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MOOG MEDICAL DEVICES CURLIN PCA INFUSION PUMP; PUMP, PCA Back to Search Results
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2014
Event Type  malfunction  
Event Description
Nurse was reconciling her patient pca infusion at end of shift.Found that patient's hourly readings did not correlate.Hour range/attempts/given/total amt totals: 7-8/0/0/0 8-9/2/1/0.8 9-10/0/0/0 10-11/1/0/0.7 11-12/0/1/0.1 12-13/0/0/0 13-14/2/1/1.4 14-15/2/1/1 15-16/0/1/0.6 16-17/2/1/1.4 17-18/6/2/2.2 pca settings: basal = 0; 0.8mg q 10 mins with max attempts = 4.No apparent patient harm.No additional medical treatment required for this patient as a result of this event.
 
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Brand Name
CURLIN PCA INFUSION PUMP
Type of Device
PUMP, PCA
Manufacturer (Section D)
MOOG MEDICAL DEVICES
4314 zevex park lane
salt lake city UT 84123
MDR Report Key3908470
MDR Text Key4495643
Report Number3908470
Device Sequence Number1
Product Code MEA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/18/2014
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 Nurse
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2014
Event Location Hospital
Date Report to Manufacturer07/02/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/18/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
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