MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITH MEDICAL CADD SOLIS EPIDURAL PUMP & TUBING; PUMP, INFUSION, PCA

Model Number CADD SOLIS

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Pain (1994)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

Epidural pump under-infused causing pain and harm to patient.Pump log states 84ml delivered but volume left in iv bag was 78ml/100ml.Only 22 mls delivered.Fda safety report id# (b)(4).

• Brand Name: SMITH MEDICAL CADD SOLIS EPIDURAL PUMP & TUBING
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15412831
• MDR Text Key: 299874599
• Report Number: MW5111996
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CADD SOLIS
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female