MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTES; SET, I.V. FLUID TRANSFER

Lot Number 4329614

Device Problem Nonstandard Device (1420)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Event Description

Solicited call, patient called back to provide cassette lot numbers.She has cassettes from lot# 4329614 which are part of the recall.She said she experienced abdominal pain when she used those cassettes.Did the reported product fault occur while in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual product available for investigation? yes.Did we replace product? yes.Did the patient have a backup product they were able to switch to? yes.Was the patient able to successfully continue their therapy? yes.Is the therapy life-sustaining? yes.No add'l info, details, or dates available.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTES
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16077480
• MDR Text Key: 306526461
• Report Number: MW5114090
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4329614
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female