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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Communication from practice liaison: "per (b)(6) at (b)(6): patient told me that, as of this morning, she has 6(as she has no spikes left for the last set up that she has).We just don't want her totally running out.Yesterday when she called in, she was calling because she had another defective cassette.If you wait for her to have 3 setups left, that's sunday for monday shipment and tuesday she is on her last cassette (and hope that none of them are defective and that the shipment comes in time)." it is unknown how many defective cassettes patient had and what the lot numbers are.It is unknown why the cassettes are defective and what the issues with them is.Pharmacy shipped out overnight delivery to patient.No further information is known.Did the reported product fault occur while in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual cassette available for investigation? unknown.Did we [mfr] replace cassette? yes.Did the patient have additional cassettes they were able to switch to? yes, if yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved, resolved? yes, ongoing? reported to (b)(6) by: health professional.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITH MEDICAL ASD, INC.
• MDR Report Key: 13426386
• MDR Text Key: 285040181
• Report Number: MW5107162
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Patient Sequence Number: 1
• Patient Sex: Female