MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-2131-25

Device Problem Failure to Infuse (2340)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical administration set was implicated in the following issue.The customer was running a cadd-solis pump with a communication module 2131.The customer reported that the pump showed error "communication module intermittent connection".According to the pump log, the error occurred in separated occasions for 7 days.The event-log also showed the error message during a patient infusion.The event log showed that the pump failed on the (b)(6) 2020 twice separate times after running an infusion program at 8:20 a.M and 12:21 p.M.There was no patient harm however, the patient had no pain relief for a number of hours until the patient was seen the next day.

Manufacturer Narrative

Other, other text: one device was returned for evaluation.Visual inspection of the device found it to have a damaged air detector.Review of the event history log found a high pressure alarm displayed, confirming the reported customer complaint.The error was noted to a result o the communication module not sitting tightly.This problem source has been determined to be manufacturing.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10752699
• MDR Text Key: 213611754
• Report Number: 3012307300-2020-10750
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517171969
• UDI-Public: 15019517171969
• Combination Product (y/n): N
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-2131-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1