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

Device Problem Failure to Prime (1492)

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

Event Type  malfunction  

Event Description

Spontaneously per pt, he got one faulty cassette, it would not let prime and so he ended up wasting 3ml of remodulin; pt made new mix and used a new cassette to get infusion going without a problem; lot is not available; pt is on iv remodulin dose 22 mg/kg using 3 ml of remodulin 2.5 mg/ml.Did the reported product fault occur with in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? yes.Did we replace device? yes.Did the patient have a backup device they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved? ongoing? resolved.Reported to (b)(6)by pt/caregiver.

• Brand Name: CASSETE MEDI RESERVOIR
• Type of Device: SET, I.V., FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10599843
• MDR Text Key: 209150638
• Report Number: MW5096913
• 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: 09/23/2020

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2020
• Patient Sequence Number: 1