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

Model Number 6400

Device Problem Pumping Problem (3016)

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

Event Date 02/26/2022

Event Type  Injury  

Event Description

Spontaneous call patient reporting that she dropped pump sn (b)(4) and now its alarming no disposable pump won't run.Had patient attempt to reattach cassette and pump still wouldn't run.Advised patient she would need to switch to back up pump and should mix new cassette.Patient added she isn't at home and didn't bring her back up pump with her.Author advised that remodulin patients can't be off remodulin for more than 4 hours.Patient will rush home to switch cassette and pump.Advised patient that pulmonary hypertension symptoms may resume the longer she is without medication.No other information available.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? unk; is the actual device available for investigation? yes; did we [mfr] replace the device? yes; did the pt have a backup device they were able to switch to? na; pt was experiencing a clot.Reported to (b)(6)/caremark by pt/caregiver.

• Brand Name: PUMP CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13660731
• MDR Text Key: 286581666
• Report Number: MW5107863
• 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: 02/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CASSETTE
• Patient Age: 65 YR
• Patient Sex: Female