MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL MEDFUSION 3500 PUMPS; ANESTHESIA CONDUCTION KIT

Model Number 3500-500

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

One infusion pump was returned for evaluation.Visual inspection of the device found it to have a cracked top case by the tube holders, and cracked on both lower left front corner and right plunger case.Device was powered on and noted to function as intended; the customer's reported complaint for acu watchdog failure was unable to duplicated.However, physical damage was noted to have a problem source of user interface.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

Event Description

Information was received that a smiths medical medfusion syringe pump had acu watchdog failure, as well as a cracked case.It was reported the incident did not occur while in use with a patient.

Manufacturer Narrative

Other, other text: additional information d10, h3, h6.Device evaluation: the device was returned for investigation.A visual inspection of the device found that the tube was broken to the welding area between the flange and the tube.The reported failure was confirmed.The most probable root cause is the failure mode reported is not attributed to manufacturing process.However, a definitive root cause was not established.A corrective and preventative action has been opened to address the reported issue.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol b10009406, as a result of warning letter (b)(4).

Manufacturer Narrative

This remediation mdr was generated under protocol b10009406, as a result of warning letter cms#(b)(4), corrected data: corrected information provided in d2.

• Brand Name: SMITHS MEDICAL MEDFUSION 3500 PUMPS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• Manufacturer (Section G): NULL; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 9729210
• MDR Text Key: 180113749
• Report Number: 3012307300-2020-01537
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 10610586032318
• UDI-Public: 10610586032318
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K040899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3500-500
• Device Catalogue Number: 3500-500
• Device Lot Number: 3792291
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 14 KG