MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7002-24

Device Problems Device Alarm System (1012); Connection Problem (2900)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that during use, the device exhibited an alarm for ¿no disposable pump will not run.¿ the pump was restarted multiple times, would run briefly, and the alarm would return.The error was not resolved.The patient presented to the clinic and was issued a new pump.The device delivered fluorouracil.Volume to be infused 100ml; rate 50ml/24hrs; volume delivered 3.65ml; volume remaining 96.4ml.Per the reporter, there were no adverse patient effects.

Manufacturer Narrative

Lot number unknown; possible lots: 4406177, 4396089, 4387666.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 information becomes available.

Manufacturer Narrative

D9: date returned to mfg (b)(6) 2024.One sample was received for evaluation.Visual inspection revealed no discrepancies.Functional testing was performed and no discrepancies were found.The reported issue was not confirmed.No lot number was provided; therefore, a history record review could not be conducted.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18869549
• MDR Text Key: 337352372
• Report Number: 9617604-2024-00218
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: 10610586022128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7002-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CADD-LEGACY ONE AMBULATORY INFUSION PUMP; FLUOROURACIL
• Patient Sex: Male