MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 4152726

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/17/2021

Event Type  malfunction  

Event Description

Spontaneous; call received from patient stating that he is trying to get the air out after mixing the cassette.Instead of air coming out, the medication is coming out from the cassette to the syringe.Reached out to richard, cnss and advised if patient has the cassette is placed correctly in the cup (diagnostically) and blue tap should face upwards.Patient said it is placed correctly and it is the first time with this issue.The cassette's lot#4152726.Advised patient to prepare a new mix.Patient said he has enough medication and supplies, and will call pharmacy on monday to place the orders.Did not occur while in use.No clinical injury.Advised patient to keep the faulty cassette.Patient will call pharmacy to place more cassettes.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? yes; did we [mfr] replace the cassette? pt has enough, he will, pharmacy to place more today.Did the pt have add'l cassettes they were able to switch to? yes.Reported to (b)(6) by pt/(b)(6).

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 12681781
• MDR Text Key: 278160921
• Report Number: MW5104854
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/17/2021

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
• Device Operator: Lay User/Patient
• Device Lot Number: 4152726
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR