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

Catalog Number 284580

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Extravasation (1842)

Event Date 09/04/2014

Event Type  Injury  

Event Description

Arthroscopic decompression, clavikelresection and cuff tear repair surgery time 2,5 hour nacl(fluid) around 20 litre a lot of red button on the pedal (increase pressure) was used during the surgery.After the surgery when they undraped the patient, they noticed that the patient was swollen across the chest and neck and arm; the anaesthesiologist decides that he cannot extubate the patient; the patient had to be placed at iva to swell of before extubation 3 hours after surgery.The patient was ok to go to the ward.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received, it will be reflected in a follow-up medwatch report.Device eval: in process.

Manufacturer Narrative

No defects that adversely affect the function of the device have been identified.No further information has been provided to determine the root cause for the failure reported.Following service activities were carried out: mechanical upgrade performed.Pneumatic circuit checked.Unit cleaned; 8-hour endurance test carried out.Unit calibrated newly.Functional test acc.To test procedure completed.Electrical safety test acc.To (b)(4) completed.Hipot test completed.Functional test performed.No other complaints have been reported on this serial number.At this point in time, no further action is warranted.However, 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.

Event Description

Arthroscopic decompression,clavikelresection and cuff tear repair surgery time 2,5 hour nacl(fluid) around 20 litre a lot of red button on the pedal (increase pressure) was used during the surgery.After the surgery when they undraped the patient they noticed that the patient was swollen across the chest and neck and arm the anaesthesiologist decides that he cannot extubate the patient the patient had to be placed at iva to swell of before extubation 3 hours after surgery the patient was ok to go to the ward.

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: FMS EQUIPMENT SYSTEMS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4122818
• MDR Text Key: 4950144
• Report Number: 1221934-2014-00426
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2014
• Date Manufacturer Received: 09/11/2014
• 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; Required Intervention