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

Catalog Number 21-7106-24

Device Problem Increase in Pressure (1491)

Patient Problems Dyspnea (1816); No Information (3190)

Event Date 07/23/2019

Event Type  Injury  

Event Description

Information was received indicating that high pressure occurred with a smiths medical cadd extension set.It was reported that the patient was airlifted to a medical center from canada, but it is unknown if the patient was admitted to the hospital or if there were any adverse effects.It was reported that subsequently the tubing was replaced.

Manufacturer Narrative

If follow-up, what type: additional information: age or date of birth, sex, event and (patient code).

Event Description

Additional information was received that a united states patient was airlifted from canada to a hospital in minnesota because he was not getting remodulin infused for about 4 hours due to defective tubing.The patient eventually found old tubing that he connected and was able to infuse.Having no remodulin for 4 hours left the patient dizzy, confused, disoriented and having difficulty breathing.The patient was admitted to the hospital for having difficulty breathing.No resuscitation measures were taken.In the physician's opinion, the cadd tubing caused or contributed to the patient's complications.The infusion was life sustaining and the patient received the remaining infusion volume at the hospital.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9098786
• MDR Text Key: 159385059
• Report Number: 3012307300-2019-04815
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/12/2024
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 3765290
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR