MAUDE Adverse Event Report: SMITHS MEDICAL CADD LEGACY PUMP

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Event Description

Patient is switching from sq remodulin to iv and one cadd pump is not working.It is beeping with an error code of 1871 and will not shut off.New pump sent per cnss request to home address for tomorrow.Rn returning pump.The patient has a back up pump in the home and her therapy was not interrupted and she did not experience an adverse event due to equipment failure.The serial number of the pump was provided.No lot or expiration date needed because the patient did not have a complaint about medication.The pump is being returned, but the medication is not defective.Dose or amount: 16ng/kg/min.Frequency: continous.Route: iv.Dates of use: 04/20/2017 to present.Diagnosis or reason for use: pah.Ndc # or unique id: (b)(4).

• Brand Name: CADD LEGACY PUMP
• Type of Device: CADD LEGACY PUMP
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6519911
• MDR Text Key: 73728719
• Report Number: MW5069300
• Device Sequence Number: 1
• Product Code: LZH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR