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

Device Problems Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949)

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

Event Type  malfunction  

Event Description

Spontaneous communication: pt reports that one of the pumps was alarming "no disposable, pump won't run".Asked patient if he pulled the blue tab off the cassette too hard after removing air and patient stated he pulls the tab off gently.Asked patient to check the cassette to see if the bladder is poking out and if so, to use a dull pencil or pen to push the little portion of the bladder that might be poking out back into the cassette to allow the cassette to be more flush against the sensor.Patient pushed the bladder back and the alarm/error stopped.The pump is functioning.Lot number unknown.No further information.All known information is contained on this form.If any additional information is received it will be provided on a separate report.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? no, pt is using it; did we replace the cassette? no; did the pt have add'l cassettes they were able to switch to? pt did not need to, it is working; is the infusion life sustaining? yes; what is the outcome of the event? resolved.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: 14470687
• MDR Text Key: 292501111
• Report Number: MW5109819
• 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: 05/18/2022

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: 05/20/2022
• Patient Sequence Number: 1
• Patient Sex: Male