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

Model Number 2100

Device Problem Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2016

Event Type  malfunction  

Event Description

A pca pump was set up at 0841.Pca settings were what was charted.At 1300 pca dose was changed and all given pca doses were deleted from am.Rn was unable to record total given doses and volume received by patient (approx 4mg).Pca pump changed for new pump.Old pump retained for review.Pca pump removed from patient room and new pump obtained.

• Brand Name: CADD-SOLIS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene, NH 03431
• MDR Report Key: 5821824
• MDR Text Key: 50405095
• Report Number: 5821824
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2100
• Other Device ID Number: 37714
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1