MAUDE Adverse Event Report: DEPUY MITEK MITEK 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 Type  Injury  

Event Description

It was reported by the sales rep that during a knee scope procedure utilizing fms duo+ pump with inflow but no outflow, fluid got into the patient's joint, causing extravasation.They used a second fms duo+ pump with the same setup and the same issue occurred.No additional information was known.The following additional information was received from our sales rep by mitek complaints on (b)(6) 2014; last week a surgeon was performing a trauma case involving a (b)(6) yo pt.I believe he repaired a fracture to the tibia after which he wanted to scope the knee.During the knee scope the patient experienced significant extravasation up into the tissue of the thigh.I was not present for this case; however, after speaking with the staff and administrators extensively here is what we believe occurred.The doctor repaired the fracture which resulted in an open incision to the knee joint.He then placed the scope into the knee joint without an outflow.The nurses told me there was significant fluid coming out of the knee through the open incision site.The doctor became frustrated with the inability of the pump to maintain pressure and instructed the staff to continually increase the pressure.After a period of time he decided the pump was faulty as it was continually pumping fluid but unable to reach the set pressure on account of the fluid loss.This may be either due to the open incision or some other breach of the capsule possibly caused by the traumatic nature of the injury.At that point they removed the first pump from the room and brought in another.The same series of events unfolded.Eventually this constant pumping of fluid into the patient caused extravasation.The following information was received via phone from our sales rep on (b)(6) 2014; the sales rep demonstrated both complaint devices without a problem.The customer & 2apos's biomed department tested both complaint devices and found no problem with either device.See associated medwatch # 1221934-2014-00389.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy synthes 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.Being held by customer.

Manufacturer Narrative

The unit was evaluated and no functional fault was found.The unit passed all diagnostic tests, functional tests, and is fully operational.Cosmetic repairs were performed on defective parts.A root cause for the reported failure cannot be discerned.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 no other 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.

Event Description

It was reported by the sales rep that during a knee scope procedure utilizing fms duo+ pump with inflow but no outflow, fluid got into the patient's joint, causing extravasation.They used a second fms duo+ pump with the same setup and the same issue occurred.No additional information was known.The following additional information was received from our sales rep by mitek complaints on august 26, 2014; last week a surgeon was performing a trauma case involving a (b)(6) pt.I believe he repaired a fracture to the tibia after which he wanted to scope the knee.During the knee scope the patient experienced significant extravasation up into the tissue of the thigh.I was not present for this case however after speaking with the staff and administrators extensively here is what we believe occurred.The doctor repaired the fracture which resulted in an open incision to the knee joint.He then placed the scope into the knee joint without an outflow.The nurses told me there was significant fluid coming out of the knee through the open incision site.The doctor became frustrated with the inability of the pump to maintain pressure and instructed the staff to continually increase the pressure.After a period of time he decided the pump was faulty as it was continually pumping fluid but unable to reach the set pressure on account of the fluid loss.This may be either due to the open incision or some other breach of the capsule possibly caused by the traumatic nature of the injury.At that point they removed the first pump from the room and brought in another.The same series of events unfolded.Eventually this constant pumping of fluid into the patient caused extravasation.The following information was received via phone from our sales rep on 9-4-14; the sales rep demonstrated both complaint devices without a problem.The customer's biomed department tested both complaint devices and found no problem with either device.See associated medwatch # 1221934-2014-00389.

• Brand Name: MITEK 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: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4063048
• MDR Text Key: 4815393
• Report Number: 1221934-2014-00388
• 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: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• 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: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2014
• Date Manufacturer Received: 08/21/2014
• 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): Required Intervention
• Patient Age: 15 YR