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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Cnss spontaneously states that pt's pumps are working fine opposed to previously recorded, the issue was the cassette.Cnss changed cassette and pumps are now working.Did cnss provide lot/expiration for cassette? no.Is the cassette available for investigation? unknown.It is unk if the product malfunctioned while in use.Did cnss state what the cassette issue was? no.Did the product issue cause or contribute to patient/clinical injury? no.Did we (mfr) replace cassette? yes.No other information known.Reported to (b)(6) by health professional.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10133001
• MDR Text Key: 194681135
• Report Number: MW5094903
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1