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

Lot Number 4329614

Device Problems Nonstandard Device (1420); Air/Gas in Device (4062)

Patient Problems Abdominal Pain (1685); Diarrhea (1811)

Event Type  Injury  

Event Description

Patient stated she had seen bubbles in cassette and patient had stomach pain and diarrhea for 3 days.Reason for side effects are unknown (unknown if due to recalled cassette) and side effects have resolved patient is using recalled cassette, lot number: 4329614, expiration date unknown.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information is available at this time.Product lot number and expiration date were systematically retrieved from the dispensing system.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? pt has minor side effects.Pt made new mis.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 therapy? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.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: 16042662
• MDR Text Key: 306182018
• Report Number: MW5113943
• 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: 12/16/2022

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: 4329614
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female