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 09/19/2014

Event Type  Injury  

Event Description

The sales rep reported that during a knee arthroscopy that the fms duo pump kept reading pressure l.The sales rep reported that the duo was being used as a solo and that in the middle of the procedure the pump began giving the error code pressure l and filled up the fill chamber, of the fms irrigation tubeset.The nurse replaced the tubing but could not get this fms irrigation tubeset to fit under the lid properly, after placing it over the wheel, so she taped the lid shut to keep it down and to keep the pump running.The surgeon completed the procedure and when the nurse removed the stocking she found the patient's leg to be rock solid, cold, and had no pedal pulse.The patient was taken to the er where the pulse returned to the leg after a 1/2 hour.The patient stayed overnight then was released and sent home.The sales rep reported that the patient is a diabetic, and has had previous surgeries to this knee not related to our devices.The customer already discarded the fms tubesets.Associated med watch # 1221934-2014-00432, 1221934-2014-00433, 1221934-2014-00434, 1221934-2014-00435.

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.In process.

Manufacturer Narrative

The unit was evaluated and the reason for return "fill chamber issue" could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.The complaint device cannot be determined to be the root cause of the reported issue.Further, a review into the depuy mitek complaints system revealed two other complaints for this serial number in the past but no failure could be confirmed.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.

Event Description

The sales rep reported that during a knee arthroscopy that the fms duo pump kept reading pressure l.The sales rep reported that the duo was being used as a solo and that in the middle of the procedure the pump began giving the error code pressure l and filled up the fill chamber, of the fms irrigation tubeset.The nurse replaced the tubing but could not get this fms irrigation tubeset to fit under the lid properly, after placing it over the wheel, so she taped the lid shut to keep it down and to keep the pump running.The surgeon completed the procedure and when the nurse removed the stocking she found the patient's leg to be rock solid, cold, and had no pedal pulse.The patient was taken to the er where the pulse returned to the leg after a 1/2 hour.The patient stayed overnight then was released and sent home.The sales rep reported that the patient is a diabetic, and has had previous surgeries to this knee not related to our devices.The customer already discarded the fms tubesets.Associated med watch # 1221934-2014-00432, 1221934-2014-00433, 1221934-2014-00434, 1221934-2014-00435.

• 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: 4144119
• MDR Text Key: 4917092
• Report Number: 1221934-2014-00431
• 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: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2014
• Date Manufacturer Received: 09/22/2014
• 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): Hospitalization; Required Intervention