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

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.

• 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 Key: 3931268
• MDR Text Key: 4572629
• Report Number: 3006540380-2014-00002
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K072053
• Number of Events Reported: 1
• 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 Number: 419102650
• Device Catalogue Number: 419102650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 06/26/2014
• 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 Number: 1
• Patient Outcome(s): Death