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

Catalog Number 284580

Device Problem Pressure Problem (3012)

Patient Problem Extravasation (1842)

Event Type  Injury  

Manufacturer Narrative

Additional 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

Whilst carrying out routine arthroscopic shoulder surgery, the pump appeared to lose regulation of water pressure within the joint.Usually in this procedure the pressure is kept at 40, but on this occasion, the shoulder collapsed after 10 minutes or so.At that juncture the pressure was increased to 45.However, with a reading of 45, the shoulder became greatly distended and the pressure of the fluid became such that it created a constant forcible jet of fluid to be expressed from the portals.In normal circumstances this effect only occurs when the pump pressure is reading above 80-90.The excessive engorgement of tissue was such that only the initial part of the procedure could be completed as tissue engorgement was such that it became impossible to navigate around the joint and the surrounding soft tissue became grossly swollen, creating a risk to soft tissue damage.This only usually occurs at much greater pressures than shown on the pump interface.The remainder of the procedure was therefore abandoned.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.On receipt of the unit we found it had sustained severe damage to the pinch valve, right safety cover and also the mains connector.These factors are not contributing to the investigation as they are all linked with transit damage.The unit was tested using the same specifications as what was recorded within the report (pressure on 40) from the customer.During the testing period the equipment did not fault or produce any error codes and functioned as expected.Flow tests and pressure test were then carried out using the fms service sheet.4 tests failed whilst doing the flow tests, the first being ¿cannula flow test without foot pedal¿ which delivered 160ml, 10ml/min out of the tolerance range.Second was ¿cannula min 200ml/min¿ which delivered 280 ml, 30ml out of the tolerance range.The third was ¿shaver min 200ml/min¿ which delivered 280ml/min, 30ml out of the tolerance range.Last test to fail was ¿shaver high 800ml/min¿ which delivered 890ml/min, 15ml out of the tolerance range.This means that the fms duo is delivering more water than expected due to the pressure adjustors being worn.The pressure tests that we carried out on the fms duo were all within specification and passed as expected.We were unable to replicate the same situation/event that the fms duo was in whilst it faulted.We have run through the fms testing specifications and found the unit to fail on 4 of the flow tests due to the pressure adjustors being worn.Further, a review into the depuy mitek complaints system revealed two dissimilar complaints for this serial number in the past.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: 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: 6136491
• MDR Text Key: 61160949
• Report Number: 1221934-2016-10517
• 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: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2016
• Date Manufacturer Received: 06/29/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other