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

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

Spontaneous; per patient he was woken by 'no disposable' error on his pump.Patient mixed a new cassette and had begun infusing prior to being connected and was no longer experiencing the error.Confirmed pump was not disturbed in a way during sleep which may have dislodged the cassette.Patient was in a hurry to get off the phone as the problem was resolved soi was unable to troubleshoot the potentially defective cassette further.Describe in detail any, and all damage to the cassette: no damage reported.This incident has not happened within the past 6 months.This patient has not reported a pump malfunction within the past 6 months.No additional info, details, or dates 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.Position of the pump when alarm occurred is unknown.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? unk; did we [mfr] replace the cassette? not as of this writing; did the pt have add'l cassettes they were able to switch to? yes.If yes, was the pt able to successfully continue their infusion? yes; what is the outcome of the event? appears 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: 16502993
• MDR Text Key: 310980317
• Report Number: MW5115533
• 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: 02/28/2023

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: 03/06/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Male