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

Device Problems Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

Spontaneous: spoke with pt regarding cadd legacy pump slow single beep.Pump shows no message initially but then it states no disposable clamp tubing.Issue started on (b)(6) 2022 and pt was able to start the backup pump without issues.Author reviewed and instructed pt to run a test using the old partially used cassette and to look at the area where the blue tab was to see if part of the cassette bladder was protruding out.Pt did confirm that this was true and using a blunt device was able to push the bladder back into the cassette.Pt replaced batteries, started pump which began infusing and continued to infuse.Author instructed pt to keep the pump running to test if it alarms again for any reason and to notify the pharmacy as needed.Pt verbalized understanding.Cassette lot number and pump serial number unknown.No further info.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Position of the pump when alarm occurred is unk.Did the reported product fault occur while in use with the pt? yes; did the issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? no; did we [mfr] replace the device? yes; was the pt able to successfully continue their therapy? yes; is the therapy life sustaining? yes; what was the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD PUMP LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14416216
• MDR Text Key: 291960688
• Report Number: MW5109733
• Device Sequence Number: 2
• 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: 05/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2022
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female