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

Device Problem Failure to Prime (1492)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous.Daughter reported nothing coming out of the tubing when trying to prime.Daughter mixed cassette, confirmed all clamps open and 3 lines displayed on screen when pressing and holding prime button.Advised daughter to try switching tubing and she opted to mix a new cassette instead.She mixed a new cassette while on the phone and confirmed she was able to prime new cassette with no issues.Lot number of cassette and tubing unknown.Unknown what caused priming error but pump working fine.No side effects reported.No further information available.Pump return tracking information is not available, photographs were not provided, this is a continuous infusion, set flow rate and volume delivered are unknown, the position of the pump when alarm occurred is unknown.No additional information is available at this time.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, but will need to send return box if needed.Did we replace the cassette? no, but can send if needed.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.Resolved? ongoing? reported to (b)(6) by: patient/caregiver.Reference report: mw5117976.

• Brand Name: LEGACY CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17030597
• MDR Text Key: 316250015
• Report Number: MW5117975
• 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: 05/23/2023

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: 05/30/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN.; TUBING.
• Patient Sex: Female