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

Device Problems Filling Problem (1233); Material Deformation (2976)

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Event Description

Patient's daughter reports patient had stroke and was hospitalized for 6 weeks; dates of hospitalization admittance and discharge are unknown.Onset/resolution dates/status of patient's stroke is unknown.Unknown if md aware.Patient's daughter also reports that for the current (1) cassette medi reservoir they have on hand, the bag inside the cassette is all wrinkled and folded and is difficult to fill without getting air bubbles.Cassette lot number is not available.No additional info, details, or dates available.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm, occurred is not applicable as no pump issue was reported.Pump return tracking information is not applicable as no pump issue was reported.Photographs were not provided.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? no; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? yes; was the pt able to successfully continue their infusion? yes; is the therapy life-sustaining? yes.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: 16832736
• MDR Text Key: 314282018
• Report Number: MW5117099
• 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: 04/17/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Patient Sequence Number: 1
• Treatment: TADALAFIL ; TREPROSTINIL
• Patient Outcome(s): Hospitalization
• Patient Sex: Female