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

Catalog Number 21-2120-0105-50

Device Problems No Flow (2991); Audible Prompt/Feedback Problem (4020)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd solis vip pump.It was reported that the device stopped pumping with repeated error code 41622.It is unknown if there was patient, or clinician injury associated with these occurrences.No further details provided at this time.

Manufacturer Narrative

Additional information: h6, h10: device evaluation: one smiths medical cadd solis vip pump was returned for analysis.During analysis, the reported issue was unable to be duplicated.It was noted that glue spot in flat gear and shaft had no lubricant.Service indicated that the expulsor needs to be replaced and bearing needs cleaning.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

• Brand Name: CADD
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12761798
• MDR Text Key: 280464090
• Report Number: 3012307300-2021-10796
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 21-2120-0105-50
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1