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

Model Number JOJ1172

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  malfunction  

Event Description

Cadd epidural pump alarmed indicating remaining volume in bag to be 40 ml, rn checked medication bag and noted 150 ml to be remaining.Cadd pump switched out after noticing error.Due to pump malfunction, the patient was experiencing pain.

• Brand Name: CADD PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 12165897
• MDR Text Key: 261473600
• Report Number: 12165897
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JOJ1172
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA