MAUDE Adverse Event Report: CASSETTE; SET, I.V. FLUID TRANSFER

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  Injury  

Event Description

Spontaneous.Pt reports that they have admitted themselves to the er due to a pump malfunction.Upon following the suggestions of the rph, the issue was actually with the cassette and not the pump.Rph on call unable to assist, so pt went to the er.Pt using ms3 pump, serial number unknown.Unknown if md aware.No other information, details or dates available.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; if yes, was any medical intervention provided? na.Did we [mfr] replace the product? no; did the pt have a backup product they were able to switch to? no; was the pt able to successfully continue their infusion? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• MDR Report Key: 15147433
• MDR Text Key: 297137887
• Report Number: MW5111209
• 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: 07/26/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female