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

Device Problem Pressure Problem (3012)

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

Event Type  malfunction  

Event Description

Spontaneous: patient's daughter stated that both pumps are getting alarms for high pressure and no disposable randomly the past couple of days.She noted it was similar to the time when the medical device correction occurred for the cassettes.She believes it to be a cassette issue and not pump malfunctions since it is happening on both.Daughter did request 1 pump replacement to try just incase along with 10 cassettes.She did not have the s/n or lot.It appears the medication is still infusing and no adverse events reported at this time.Unknown if md is aware.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? yes; did we [mfr] replace the cassette? yes; 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; is the infusion life sustaining? yes; what is the outcome of the event? ongoing.Reported to (b)(6) by pt/caregiver.Reference report mw5115503.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16501722
• MDR Text Key: 310952347
• Report Number: MW5115504
• 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: 03/03/2023

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: 03/07/2023
• Patient Sequence Number: 1
• Patient Sex: Female