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

Device Problem Leak/Splash (1354)

Patient Problems Overdose (1988); Underdose (2542)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received that the cadd extension set was leaking at the filter during administration.Patient first suffered from under dose during infusion and then experienced overdose after changing the infusion line.

Manufacturer Narrative

Device evaluation: one smiths medical cadd extension set was returned for analysis in a used condition.During analysis, visual inspection was performed and found no discrepancies.Leak test was performed using hydrostat vessel and leak was detected in the air vent of the filter.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8307660
• MDR Text Key: 135081553
• Report Number: 3012307300-2019-00376
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1