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  

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.

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.

• 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: 18326002
• MDR Text Key: 330573746
• Report Number: 9617604-2023-00015
• 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: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2023

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: Lay User/Patient
• Device Model Number: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 4381268
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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