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

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Patient came in and his cadd pump tubing was disconnected from the equashield.States happened about 3 am.Noticed immediately.The huber needle still intact.No white or chemo noted around the site.The connector sites were taped appropriately.Es were taped.

• Brand Name: CADD PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 15417036
• MDR Text Key: 299855255
• Report Number: 15417036
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/06/2022,09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/14/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Race: Black Or African American