MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION SYNRINGE INFUSION PUMP; PUMP, INFUSION, PRODUCT CODE: FRN

Model Number 3500

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: returned device was received with the right plunger case cracked.Evidence of reported problem in event log was found.During the evaluation of the device he customer reported condition was unable to determine.Problem source is unknown.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service & repair records.

Event Description

It was reported that the smiths medical medfusion synringe infusion pump had a "primary audible alarm".No adverse patient effects were reported.

• Brand Name: MEDFUSION SYNRINGE INFUSION PUMP
• Type of Device: PUMP, INFUSION, PRODUCT CODE: FRN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10016437
• MDR Text Key: 189570643
• Report Number: 3012307300-2020-03588
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586032318
• UDI-Public: 10610586032318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3500
• Device Catalogue Number: 3500-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1