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

Model Number 6400

Device Problems Increase in Pressure (1491); Defective Device (2588); No Flow (2991)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

Via spontaneous call, patient's daughter who stated that she has prepared new cassette, but pump is alarming for high pressure (serial number (b)(4)).Asked if there are any kinks in the tubing or if there are any clamps on.Patient's daughter stated no.Pt's current pump is running fine with current cassette.Advised her to switch new cassette to pt's current pump, which she did so, but pump alarmed for high pressure.Again, no kinks or clamps.Daughter stated that tubing is pinched on top of cassette and it looks to be a tight squeeze.Advised that could be the problem and instructed her to make brand new cassette.Once daughter attached new cassette with new tubing to pump and pressed prime, pump alarmed again for high pressure.Again, no kinks or clamps.Daughter tried switching new cassette to former pump.Then call got suddenly disconnected.Made several calls to patient and patient's daughter.Will continue to follow-up.Did we replace device? still determining whether this is pump / cassette issue.Is the infusion life-sustaining? yes; what is the outcome of the event? ongoing.Waiting to hear back from pt.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device is available to be returned for investigation? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12672606
• MDR Text Key: 278117409
• Report Number: MW5104823
• Device Sequence Number: 3
• 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: 08/04/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR