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

Lot Number 4235253

Device Problems Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

Spontaneous report from patient stating that they only have 7 days left on hand of remodulin but should have more.Cassette and tubing malfunction reported.Patient was not able to get all of the air out of 4 cassettes because the pouch was wrinkled on the bottom.Cassette lot numbers 4235253 [2 cassettes], 4257805 (1 cassette) and 4235250 (1 cassette).Pt also reports that 2 of their tubing sets randomly unscrewed on their own (lot number 4196376 and 4235184).Confirmed with pt that tubing was attached correctly.Pt has cassettes and tubing available for return if needed.No further information, details or dates available.All known information is contained on this form.If any additional information is received it will be provided on a separate report.Did the reported product fault occur while in use with the pt? no; 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? 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: 14408448
• MDR Text Key: 291837044
• Report Number: MW5109710
• 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: 05/04/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4235253
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2022
• Patient Sequence Number: 1
• Patient Sex: Female