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

Device Problems Break (1069); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous: pt reported issues with 2 of her cassettes in her recent order.She stated one cassette's blue piece, at the top was completely missing and on the other cassette, that the green piece was broken.Pt was able to switch to a working cassette and did not miss any medication.We are sending new cassettes out for tomorrow.Products are available fer return if needed.Pt did not have lot number of products.Did the reported product fault occur while in use with patient? yes; did the product issue cause or contribute to patient or clinical injury? no; are the cassettes available for return? yes; outcome: resolved, medication is life sustaining.Incident did not happen in the last 6 months patient has not had pump issue in last 6 months (last issue was (b)(6)2021) no further information available.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13758319
• MDR Text Key: 287271023
• Report Number: MW5108143
• 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: 03/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female