MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD PRIZM HIGH VOL. ADMIN. SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7364-24

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported that the device over delivered the medication.No patient injury was reported.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: samples were returned for investigation.The returned samples were visually inspected under normal conditions of illumination according to the inspection procedure.No visually discrepancies were detected.The samples were set for accuracy testing using a cadd pump to look for unusual function according to the procedure.Two of the three samples passed the test, thus confirming the failure mode.The root cause was traced to manufacturing.A capa was opened to investigate the under-delivery/ non-delivery issue as well as for corrective action.A batch review was conducted to the lot number reported, the results concluded that no deviations and no non-conformances were open during the manufacture of the lot related to the issue reported.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD PRIZM HIGH VOL. ADMIN. SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15756175
• MDR Text Key: 306004092
• Report Number: 3012307300-2022-26925
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191776
• UDI-Public: 15019517191776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7364-24
• Device Catalogue Number: 21-7364-24
• Device Lot Number: 3984052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1