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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL FLOW SYSTEMS LTD ACTION BLOCK PUMP; PUMP, INFUSION PUMP, ELASTOMERIC

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MEDICAL FLOW SYSTEMS LTD ACTION BLOCK PUMP; PUMP, INFUSION PUMP, ELASTOMERIC Back to Search Results
Model Number 419102650
Device Problems Free or Unrestricted Flow (2945); Installation-Related Problem (2965)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 06/18/2014
Event Type  Death  
Event Description
On (b)(6) 2014, we received phone call from our us distributor informing a "free-flow" incidence resulted of wrong installation of one of our pumps had occurred, pt passed away, farther detailed info will be submitted asap.On (b)(6) 2014, we had received from our distributor first info (partial) related to the incidence: a nurse in the pacu of the va was supposed to prime the regulator, attach it to the reservoir and then hook up the pt.The ending result was the nurse hooked to reservoir directly up to the catheter.The procedure was a total knee and the catheter was placed in the femoral/groin area for a femoral nerve block.The anesthesiologist confirmed that the pump was mistakenly connected directly to the catheter.The entire reservoir emptied in the pt.The pt eventually went into cardiac arrest and passed away that day.Medical facility: (b)(6).
 
Manufacturer Narrative
Since the device lot yet not reported, we can't trace the mfg date.Eval method: based on the received incidence report.The regulating set includes a flow regulator that controls the administration flow rate.Having the catheter connected directly to the exit port of the reservoirs, tubing will result with free pressurized flow through the catheter.Based on the incidence report, the incidence is resulted of user (authorized medical team member) error.The directions for use are clear on proper assembly of the pain pump.Had the facility followed the direction of use, this event would have been avoided.
 
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Brand Name
ACTION BLOCK PUMP
Type of Device
PUMP, INFUSION PUMP, ELASTOMERIC
Manufacturer (Section D)
MEDICAL FLOW SYSTEMS LTD
shlomi
IS 
Manufacturer Contact
ofer shay
po box 26, elt building
dora industrial zone
shlomi 22832
IS   22832
49808280
MDR Report Key3931268
MDR Text Key4572629
Report Number3006540380-2014-00002
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K072053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number419102650
Device Catalogue Number419102650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/24/2014
Initial Date FDA Received06/26/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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