MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS NRFIT - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7609-24

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported the disposable caused the device to exhibite a no disposable pump will not run" alarm after 145ml of a 247ml dose was infused.The pharmacy confirmed that 90ml remained in cassette.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: 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.B3: date of event is unknown.

Manufacturer Narrative

Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.

• Brand Name: CADD CASSETTE RESERVOIRS NRFIT - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17624340
• MDR Text Key: 321976713
• Report Number: 3012307300-2023-08398
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: 10610586044014
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162219
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7609-24
• Device Lot Number: 4342759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1