MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD® EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Obstruction of Flow (2423)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Information was received indicating that a patient was hospitalized twice for a line blockage.The patient uses a smiths cadd legacy pump to provide therapy but is unknown if the device caused the reported event.It was also reported that the patient developed a low blood pressure while in the hospital.

Manufacturer Narrative

Additional information: additional information was received indicating patient weight and that the patient passed away in (b)(6) 2019.It was stated that the patient had pumps with serial number (b)(4) and (b)(4) but the reporter was unable to confirm which pump was in use at the time of the reported event or last in use.

• Brand Name: CADD® EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8382909
• MDR Text Key: 137574680
• Report Number: 3012307300-2019-01081
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Weight: 55