MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO MITEK FMS PUMPS

Catalog Number 284580

Device Problem Device Operational Issue (2914)

Patient Problem No Code Available (3191)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

Event Description

It was reported by the biomed that during a unknown procedure the pump run off suddenly and the fill chamber was full. There is a risk that some liquid went through the pressure sensor inside the pump. Hotline agent recommend to stop using the pump and send it to repair. The call was during the procedure with patient on table, at that moment they did not know how they will complete the case. No patient consequences. Additional information received via email 9-29-2016. I have got more information about this case. The surgeon had to change the technique because he could not use the pump anymore and did not have a spare one. They opened directly the patient. The surgery delay was over 30 minutes, and there is no consequences on the patient.

Manufacturer Narrative

The defect reported could not be verified. A review into the depuy mitek complaints system revealed two other complaints for this serial number with pressure issues. Root cause for the reported failure could not be determined as there was no issue found with the device. At this point in time, no further action is warranted. However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed. Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: MITEK FMS PUMPS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6062780
• MDR Text Key: 58600158
• Report Number: 1221934-2016-10451
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2016
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/28/2016 Patient Sequence Number: 1