MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD PUMP; PUMP, INFUSION

Device Problems Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Arrhythmia (1721); Increased Respiratory Rate (2486)

Event Date 11/30/2021

Event Type  Injury  

Event Description

Spontaneous.Per practice liaison, (b)(6) (nurse) at (b)(6): "last night patient had pump malfunction and went to emergency department with palpitations and tachypnea.Pump was beeping "cartridge not detected." even after she changed cartridge then finally changed pump with resolution.She was provided with a replacement pump from (b)(6)." no additional info available.Unknown if md aware, event occurred while patient was using pump, follow up with patient this pump is now currently working- (b)(6) pump- not programmed.Patient receiving life sustaining medication and has been discharged from hospital (date unknown) event has been resolved.Reported to (b)(6) by health professional.

• Brand Name: CADD PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 12954549
• MDR Text Key: 281938295
• Report Number: MW5105875
• Device Sequence Number: 1
• Product Code: FRN
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: CASSETTE
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female