MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY PUMP; SET ADMINISTRATION INTRAVASCULAR

Model Number 6400

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Event Description

Spontaneous call from pt stating this pump is not working.Pump will not recognize the new cassette.New replacement will be sent to pt.Has backup pump that he is using.No other issues reported.No adverse event.Serial number (b)(4) - spontaneous.No other info available.Did the reported product fault occur while in use with a pt? no; did the product issue cause or contribute to pt or a clinical injury? no; is the actual device available to be returned for investigation? yes.Did we replace device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD LEGACY PUMP
• Type of Device: SET ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; st. paul MN
• MDR Report Key: 8504173
• MDR Text Key: 141789715
• Report Number: MW5085795
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Device Lot Number: 999999999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 51 YR