MAUDE Adverse Event Report: SMITHS MEDICAL MEDICATION CASSETTE RESERVOIR 100ML; SET, IV - FLUID TRANSFER

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Patient reports 1-2 weeks ago she went to mix and the pump alarmed "high pressure" before she connected to iv line.The patient took the same mixed cassette and connected it to the other pump and it also alarmed "high pressure".She switched back and forth again and go the same result.She called her "better half" who came back from work and thought it was probably the cassette.The patient remixed a new cassette and was able to start infusion without any problems.Her husband took a tooth pick and tried to poke where the remodulin would have come out but was unable to push the toothpick through.No other info known.Dose or amount: 1, frequency: as directed, route: na.Dates of use: from (b)(6) 2010 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: MEDICATION CASSETTE RESERVOIR 100ML
• Type of Device: SET, IV - FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL; dublin OH
• MDR Report Key: 7340847
• MDR Text Key: 102643491
• Report Number: MW5075871
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1