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

Lot Number 4315909

Device Problem Nonstandard Device (1420)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Type  malfunction  

Event Description

Patient reported she has gotten a rash on her face about 4 days ago.She has tried benadryl which has helped with itchiness a little.Patient also has cassettes affected by the recall.Patient has 12 cassettes with lot: 4315909, expiration date unknown.Unknown if cassette recall contributed to rash.Unknown if patient was infusion with a impacted recall lot cassette at time event occurred.No other information known.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.Did the reported product fault occur while in use with the pt? unk; did the product issue cause or contribute to pt or clinical injury? unk; is the actual product available for investigation? yes; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? yes, upon replacement; was the pt able to successfully continue their therapy? yes; is the therapy life sustaining? yes.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: 16043509
• MDR Text Key: 306272527
• Report Number: MW5113987
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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
• 12 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4315909
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EPOPROSTENOL
• Patient Sex: Female