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

Lot Number 4329614

Device Problem Nonstandard Device (1420)

Patient Problems Adult Respiratory Distress Syndrome (1696); Muscle Weakness (1967); Dizziness (2194)

Event Type  Injury  

Event Description

Call from patient who reported symptoms as well as cassettes that are on the recall list.Patient has 9 cassettes with lot#: 4329614 and 1 cassette with lot#:4284652.It is unknown which cassette patient is using at this time.Patient reports since last weekend patient has experienced light headedness, excessive tiredness and more difficulty walking (due to shortness of breath).Side effects reported are ongoing.Patient believes some of her symptoms are due to cassette recall.No other information known.Occur with use clinical injury yes medical intervention advised pt.To go to hospital if symptoms worsen available for investigation replaced.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? yes.If yes, was any medical intervention provided? advised patient to go to hospital if symptoms worsen, is the actual cassette available for investigation? yes, did we replace the cassette? yes,did the patient have additional cassettes they were able to switch to? no, if yes, was the patient able to successfully continue their infusion?, if no, what was the patient instructed to do in able to continue their infusion? go to hospital, is the infusion life-sustaining? yes, what is the outcome of the event? ongoing, resolved?, ongoing? reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16051921
• MDR Text Key: 306323778
• Report Number: MW5114018
• 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
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4329614
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2022
• Patient Sequence Number: 1
• Patient Sex: Female