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

Model Number 6400

Device Problems Use of Device Problem (1670); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Spontaneous.Pt reports a pump issue (serial number (b)(4)), error message: no disposable, clamp tubing.This is the 3rd time in the past couple of months that pt has had a pump issue; no dates provided.Pt is a physician who has a good understanding of this therapy, the devices, and the workings of a good central line.Pt has tried working with the pumps each time to discover what the actual problem is [changing batteries, cassettes, tubing, pumps, etc].When switching to the back-up pump, it was working properly, but pt believes that the issue could also certainly be from a bad batch of cassettes for it to happen this frequently.All cassettes seem to be from lot number 3621 and issue reported with the last cassette is from that batch.Pt attempted to connect another cassette from lot number 3621 while on the line and it gave the same error message.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 cassette available for investigation? no; did we [mfr] replace the cassette? yes; did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Pt had working cassettes to use.Ongoing? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12878222
• MDR Text Key: 281421109
• Report Number: MW5105601
• Device Sequence Number: 3
• 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: 11/04/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2021
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male