MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. SET, ADMIN, HIGH VOL, 1.2 FLTR, NAC, FS, TOTM 15/BX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7364-24

Device Problems Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that the pump did not deliver the medication to the patient although the pump indicated that the medication was delivered.The pump did not alarm.It was unknown if there were any adverse patient effects.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.B3 unknown, h3: device has not been returned to manufacturer.

Manufacturer Narrative

No product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: SET, ADMIN, HIGH VOL, 1.2 FLTR, NAC, FS, TOTM 15/BX
• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18504787
• MDR Text Key: 333098734
• Report Number: 9617604-2024-00040
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191776
• UDI-Public: 15019517191776
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7364-24
• Device Catalogue Number: 21-7364-24
• Device Lot Number: 4308526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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 PUMP