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

Model Number 21-7346-24

Device Problems Device Alarm System (1012); Partial Blockage (1065); Complete Blockage (1094); Obstruction of Flow (2423); Blocked Connection (2888)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the disposable made the device alarm "down stream occlusion".Patient was sent to fmc hptp to have additional troubleshooting done and the remainder of vancomycin infused.No patient injury reported.

Manufacturer Narrative

One disposable was received for evaluation.Visual inspection found the disposable to be in used condition, and the bond between the coil tube and entrance of the filter was observed to be occluded.To conduct functional testing, the disposable was primed and set to be ran with a cadd legacy pump.He fluid did not pass through the unit and the alarm high pressure? was activated.The reported failure mode, pump alarm, is confirmed.The root cause was determined to be the occlusion in the bond between the coil tube and filter entrance due to an excess of solvent.This was caused by failure to properly follow manufacturing procedure.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17010454
• MDR Text Key: 316039420
• Report Number: 3012307300-2023-05736
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female