MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. RESERVOIR, CASSETTE, 250ML, FS 12/BX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7308-24

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that the device infused faster than the 46-hour programmed infusion.The infusion ended five to six hours early.Per reporter the patient experienced a stomachache, no other adverse patient effects were reported by the customer.The device settings were reviewed, air in line was noted.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.H3: device has not been returned to manufacturer.

Manufacturer Narrative

D9: date returned to mfg 1/17/2024.One sample was returned for evaluation.Visual inspection revealed no discrepancies found in the device.During functional testing, the device failed.The failure mode of ¿delivery, over infusion¿ was confirmed.No lot number was provided; therefore, a history record review could not be conducted.D4 - lot # unknown; reported as either 4381267 or 4381268.D4 - expiration date and h4 unknown.

• Brand Name: RESERVOIR, CASSETTE, 250ML, FS 12/BX
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana CA ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18325911
• MDR Text Key: 330493390
• Report Number: 9617604-2023-00014
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586032374
• UDI-Public: 30610586032374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081156
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 4381267
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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: 5-FLUOROURACIL; CADD EXTENSION SET; CADD PUMP