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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP COMBO; FMS EQUIPMENT SYSTEMS
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DEPUY MITEK 4580 FMS DUO+ PUMP COMBO; FMS EQUIPMENT SYSTEMS Back to Search Results
Catalog Number 284580
Device Problems Unknown (for use when the device problem is not known) (2204); Device Operates Differently Than Expected (2913)
Patient Problems Surgical procedure, delayed (2565); No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2015
Event Type  Injury  
Event Description
It was reported by the customer that the pump was causing the tubing to collapse.Customer tried a second pump and the suction was running constantly.Customer stated that the patients shoulder had become swollen during the procedure and the procedure was prolonged for approximately one hour.No patient consequences.Both pumps being returned.See associated medwatch # 1221934-2015-00837.
 
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.
 
Manufacturer Narrative
The complaint device was returned and forwarded to a supplier for evaluation.Visually, the device had no anomalies.The inspection revealed that the unit passed all diagnostic tests, function tests, and is fully operational.The reported condition could not be replicated and could not be confirmed.As a note, servicing was done on the device to replace worn out fingers on the complete pressure adjusters as a preventative maintenance.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this serial number released for distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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 customer that the pump was causing the tubing to collapse.Customer tried a second pump and the suction was running constantly.Customer stated that the patients shoulder had become swollen during the procedure and the procedure was prolonged for approximately one hour.No patient consequences.Both pumps being returned.See associated medwatch # 1221934-2015-00837.
 
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Brand Name
4580 FMS DUO+ PUMP 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
eric so
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4864832
MDR Text Key5847771
Report Number1221934-2015-00838
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,health professional,use
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 05/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/28/2015
Event Location Hospital
Date Report to Manufacturer05/29/2015
Date Manufacturer Received05/29/2015
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 Number1
Patient Outcome(s) Required Intervention;
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