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

Model Number 21-7324-01

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information was received indicating that during an epidural administration, a smiths medical cadd administration set was inserted into a cadd solis vip pump.When the bolus button was pressed, no bolus was delivered and no error message was identified.The customer assumed it was an administration set issue, to the administration set was changed with another lot number, then the bolus administration was successful.There was no reported adverse event or clinical consequence for the patient.

Manufacturer Narrative

Device evaluation: one smiths medical cadd administration set was returned for analysis.Visual inspection was performed under normal conditions of illumination and no obstructions nor other workmanship defects were detected in none of the joints of the product, only a kink was detected on the pump tube in the sample.Accuracy testing was performed using a pump solis vip to look for unusual function and no discrepancies were detected, and the accuracy test was passed successfully.Based on the evidence, the complaint was not confirmed, and no fault was found.

• Brand Name: CADD ADMINSTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9208577
• MDR Text Key: 173930186
• Report Number: 3012307300-2019-05589
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7324-01
• Device Catalogue Number: 21-7324-24
• Device Lot Number: 3793891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CADD SOLIS VIP PUMP