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

Lot Number 4321040

Device Problem Nonstandard Device (1420)

Patient Problem Tachycardia (2095)

Event Type  Injury  

Event Description

Pharmacist reached out to patient to provide updated estimated arrival time for their iv treprostinil couriered for arrival today.Patient reports that she has 5ml of medication left at this time.Patient reported her pulse is now 131 beats per minute and oxygen saturation is normally high 90's (99 on a good day) and is now 93.Pharmacist recommended to patient, again, that she goes to the hospital.Patient was consulted previously today by another pharmacist who also recommended patient go to th hospital (separate report submitted).Patient said she may go.Patient reports she received a phone call form her md.Md has already called bergan mercy hospital, omaha to inform them of the situation and that she may show up.Patient only has recalled cassettes on hand, lot: 4321040, expiration date unknown.Patient will also be receiving replacement cassettes.Patient reported that her boyfriend could take her to the hospital and said again she may end up going.Pharmacist informed patient to have hospital staff call pharmacy if she goes for any questions.No additional information.Pump tracking is not applicable.Photographs not provided.Continuous infusion.Set flow rate/volume delivered are unknown.Position of pump is not applicable.No additional information available at this time.Did the reported fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? yes; if yes, was any medical intervention provided? advised to go to hosp.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? no; if no, what was the pt instructed to do in able to continue their infusion? advised to go to hosp; is the infusion life sustaining? yes; what is the outcome of the event? ongoing.Reported to cvs/caremark 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: 16043474
• MDR Text Key: 306240957
• Report Number: MW5113982
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4321040
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Sex: Female