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

Model Number 419106650

Device Problems Improper or Incorrect Procedure or Method (2017); Installation-Related Problem (2965)

Patient Problems Overdose (1988); Seizures (2063)

Event Date 01/31/2014

Event Type  Injury  

Event Description

Pt received significant overdose volume of medication as result of incorrectly device installation.Pt seized and had to be hospitalized, but recovered with no further issues.

Manufacturer Narrative

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.No preventative and/or corrective actions are required.The procedure on how to assemble the pump prior to use is clear and explained in detail and illustrated with drawings in physician guidelines and instructions.Based on the visual photo eval 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 directions for 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 bld, dora indust zone; shlomi ; IS ; 49808280
• MDR Report Key: 3676769
• MDR Text Key: 21310649
• Report Number: 3006540380-2014-00001
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/20/2014

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 Expiration Date: 05/31/2015
• Device Model Number: 419106650
• Device Catalogue Number: 419106650
• Device Lot Number: 15471501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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): Required Intervention