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

Model Number 6400

Device Problems Defective Device (2588); Protective Measures Problem (3015); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Event Description

Per pharmacist note, per patient alarming for no disposable pump and then patient pressed next but pump shut off completely and also per pt and pt husband cassette seemed different where the bag was sticking out too much from the top unsure whether this is just a pump malfunction or cassette malfunction or both per reporting rph.Patient did not have lot number for cassette.No further information known.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual cassette available for investigation? yes.Patient told to set a side cassette in case it needs to be returned.Did we [mfr] replace the cassette? yes.Did the patient have additional cassettes they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved, resolved? ongoing?.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CADD PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13290662
• MDR Text Key: 284287703
• Report Number: MW5106790
• Device Sequence Number: 1
• Product Code: LHI
• 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: 01/14/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female