MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION® 3500 V6 SYRINGE PUMP; ACCESSORIES, PUMP, INFUSION

Model Number 3500-0600-01

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported the medfusion® 3500 v6 syringe pump experienced a check clutch plunger lever alert.It is also reported the device was not in clinical use at the time the alert occurred and did not cause patient injury.

Manufacturer Narrative

One medfusion® 3500 syringe infusion pump was returned for investigation.Visual inspection of the returned device revealed that the device was in poor condition; the plunger head was observed to have contamination inside along the main board.It was also observed that the position potentiometer had contamination; the position potentiometer was replaced.A review of the device event history log found that a check clutch/plunger lever error had occurred.During functional flow testing, the check clutch/plunger lever error was able to be duplicated.Investigation determined that the check clutch/plunger lever error was due to fluid ingression into the main body of the device as a result of the improper cleaning of the pump.After device repair and recalibration, the device was found to pass all delivery, accuracy and functional tests.

• Brand Name: MEDFUSION® 3500 V6 SYRINGE PUMP
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL OAKDALE; 3350 granada avenue north; suite 100; oakdale, MN 55128
• Manufacturer Contact: lisa perz ; smiths medical asd, inc.; 6000 nathan lane north; minneapolis,, MN 55442 ; 7633833074
• MDR Report Key: 6254793
• MDR Text Key: 64916985
• Report Number: 3012307300-2017-00169
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

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: Service Personnel
• Device Model Number: 3500-0600-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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