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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient reported having a bunch of "crumpled up" cassettes that he has been setting to the side.Patient stated the bladder of the cassette is very crumpled up and oversized.Patient stated he is too scared to use those cassettes and doesn't want to waste any medication because he has had issues in the past with having cassette malfunctions.Patient stated he has about 24 cassettes on hand set aside that are very "crumpled up" and that he does not want to use.Patient provided a reference number 21-7302-24, and did not provide any lot numbers.Patient confirmed he has enough good cassettes cii hand to use until his next order arrives.No additional information provided.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.If yes was any medical intervention provided? is the actual cassette available for investigation? yes.Did we replace the cassette? no.Did the patient have additional cassettes they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.If no, what was the patient instructed to do in able to continue their infusion? is the infusion life-sustaining? yes.What is the outcome of the event? resolved? ongoing? resolved.Reported to (b)(6) by: patient/caregiver.Reference reports: mw5146163, mw5146164, mw5146165, mw5146166, mw5146168, mw5146169, mw5146170, mw5146282, mw5146171, mw5146172, mw5146173, mw5146174, mw5146175, mw5146176, mw5146177, mw5146178, mw5146179, mw5146180, mw5146181, mw5146182, mw5146183, mw5146184, mw5146185.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17824796
• MDR Text Key: 324709952
• Report Number: MW5146167
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 09/19/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN MDV.; STERILE DILUENT FOR REMODULIN.
• Patient Sex: Male