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

Catalog Number 21-7381-01

Device Problems Insufficient Flow or Under Infusion (2182); Intermittent Infusion (2341); Improper Flow or Infusion (2954)

Patient Problem No Code Available (3191)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: foreign country: (b)(6).

Event Description

Information was received indicating that a smiths medical cadd high-volume administration set had air in the line during total parenteral nutrition (tpn) infusion.It was reported that the patient experienced coughing fits.No further details were provided about effect to patient.

Manufacturer Narrative

Video was received and it could be observed that the line before the filter was completely filled with medication, but most of the line after the filter is full with air; only a bubble air was showed trapped in the system.Device evaluation: one smiths medical cadd administration set was returned for analysis.During analysis, the sample was connected to a hydrostat vessel in order to prime the devices.The air vent side of the filter could not be completely filled; fluid and air passed through the membrane to the rib side and then to the outline.It was noted that the most probable root cause was alleged to be that the filter was received damaged from the supplier, and that the damage occured after the product left shm facility.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be supplier.Dhr review was performed and showed that there were no relevant findings on the dhrs.

• Brand Name: ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8984515
• MDR Text Key: 163057765
• Report Number: 3012307300-2019-04677
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2023
• Device Catalogue Number: 21-7381-01
• Device Lot Number: 3730617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CADD PRIZM PUMP