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

Device Problems Loose or Intermittent Connection (1371); Infusion or Flow Problem (2964); Material Protrusion/Extrusion (2979)

Patient Problems Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930)

Event Date 05/07/2023

Event Type  Injury  

Event Description

Iv remodulin -pt reported that they are in the hospital right now - she was admitted last night- iv line infection- site was red and a little pus coming out of the line.Pt was started on a medication of which, name not provided.Meanwhile, pt called to report that she has no disposable alarm - reviewed possible reason (internal bladder that holds medication comes up through corner, just enough to interfere with connection to pump sensor.So by simply poking that little portion of bladder back into cassette with pen or pencil, allows cassette to be more flush against sensor).Pt voiced understanding and she was able to fix it and no alarm anymore.She had same problem in the morning.Pt did not asked to replace her pump but if any more problems - advised to change cassette to new one and call us if not fixed so we can replace pump/cassette - no more questions or concerns.No additional information, details, or dates are available.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are not known.Position of the pump when alarm occurred is not known.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? no.If yes, was any medical intervention provided? n/a.Is the actual cassette available for investigation? no.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? n/a.Is the infusion life-sustaining? yes.What is the outcome of the event? - resolved.Resolved? yes.Ongoing? n/a.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE LEGACY MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16911077
• MDR Text Key: 315106724
• Report Number: MW5117455
• 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: 05/08/2023

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: 05/10/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female