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

Lot Number 4329622

Device Problems Defective Component (2292); Improper Flow or Infusion (2954); Material Twisted/Bent (2981)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

Patient reported issue with cassettes.Patient has 5 defective cassettes lot number: 4329622/expiration date unspecified.This lot number is outside of the lot numbers that were recalled a month ago.Reviewed to quarantine cassettes and pharmacy would send return box and replacement patient said that usually she notices the cassette is defective prior to hooking up to pump but one of the cassettes malfunction and "pinched off" while in use.Patient was out at the movies and realized she wasn't getting any medication and was feeling short of breath, patient was able to switch to back up cassette that she brought with her and was able to continue treatment.Unsure how long she went without medication.Exact dates unknown.No other information known.Product lot number and expiration date were systematically retrieved from the dispensing system.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? shortness of breath due to pause in infusion.If yes, was any medical intervention provided? no.Is the actual device 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.(b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16195384
• MDR Text Key: 307716796
• Report Number: MW5114361
• Device Sequence Number: 2
• 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: 01/12/2023
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4329622
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTENSION SET.; PUMP.; VELETRI.
• Patient Sex: Female