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

Device Problems Defective Component (2292); Pressure Problem (3012); Activation Failure (3270)

Patient Problems Diarrhea (1811); Taste Disorder (4422); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Spontaneous report.Pt daughter stated on (b)(6) 2023 they were mixing new cassette but pump kept alerting for high pressure during priming; daughter stated she tried to troubleshoot by disconnecting an reconnecting, turning off and on pump but unable to resolve; pt daughter stated mixed a new cassette and had no further issues; pt daughter stated pt was still connected to old pump and cassette so pt did not stop infusing and had no gaps in therapy; pt stated she does not have sn of cassette as she had already thrown the malfunctioned cassette away; advised for future to hold on to any malfunctioned cassettes; daughter also mentioned that pt experiencing an increase in diarrhea, swelling.And has been noticing some diminished taste; discussed side effects of medication and when to seek medical attention; advised f/u with mdo as well; pt daughter verbally understood; pt uses iv remodulin with cad legacy pump; no other information known.Did the reported product fault occur while in use with the pt? no; 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.Reported to (b(6) by pt/caregiver.Ref report: mw5115266.

• Brand Name: CADD LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16452290
• MDR Text Key: 310515585
• Report Number: MW5115267
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: CASSETTE; REMODULIN ; TUBING
• Patient Sex: Female