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

Lot Number 4321040

Device Problem Nonstandard Device (1420)

Patient Problems Diarrhea (1811); Headache (1880); Hypoxia (1918); Nausea (1970); Pain (1994); Syncope/Fainting (4411); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Spontaneous communication, patient reported she has 20 recalled cassettes with lot number: 4321040 expiration date unknown, and zero non-affected cassettes on hand.At time of report, patient infusing with affected lot number.Patient reports not being able to breathe and passing out, low oxygen levels, at times she notices the side effects are felt more than before headache, jaw pain, nausea, diarrhea, bloating, belching.Unknown onset date of side effects.Side effects are ongoing.Patient was recently admitted to the hospital from (b)(6).The nearest hospital with the medication or able to manage veletri is 2.5 hours away, patient has a sick "fianc" and can't go to the emergency room and she's so tired and says she can't go again right now.Product lot number and expiration date were systematically retrieved from the dispensing system.Pharmacy to send replacement cassettes, advised if any issues go to the emergency room and if any assistance is need to call us.Unk if recalled cassettes caused adverse event.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 applicable.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? yes; if yes, was any medical intervention provided? hospitalization; is the actual cassette available for investigation? yes; did we mfr replace the product? yes; did the pt have add'l cassettes they were able to switch to? no.Was the pt able to successfully continue their infusion? yes, with impacted cassette; if no, what was the pt instructed to do in able to continue their infusion? pt was also advised to go to er due to side effects reported.Is the infusion life sustaining? yes; what is the outcome of the event? ongoing.Reported to cvs/caremark 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: 16043419
• MDR Text Key: 306208139
• Report Number: MW5113974
• Device Sequence Number: 2
• 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: 12/16/2022
• 20 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female