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

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problems Chest Pain (1776); Dizziness (2194)

Event Type  Injury  

Event Description

Patient reported of going to er due to having issues with cassettes; beeping and displaying "high pressure." she stated she was having chest pain and lightheadedness.Lot number/expiration date for cassette used at time of event is unknown.Patient is to call back (once she has access to cassettes) to confirm if she has the recalled cassettes on hand.Patient was able to run the medication without interruption when a new cassette was used on the same pump, so not a pump issue.Date and length of er stay is unknown.Side effects resolved, date of resolution unspecified.Patient is unsure if product complaint contributed to side effects experienced.No other information available.Dose or amount: treprostinil 20 ng/kg/min.Pump return tracking info is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of pump when alarm occurred is not known.No add'l info is available at this time.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? not known.Is the actual product available for investigation? no.Did we [mfr] replace the product? yes.Did the pt have a backup product they were able to switch to? yes.Was the pt able to successfully continue their therapy? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16122532
• MDR Text Key: 307021262
• Report Number: MW5114231
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Sex: Female