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

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.

• 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 Key: 3908470
• MDR Text Key: 4495643
• Report Number: 3908470
• Device Sequence Number: 1
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 FDA: 06/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR