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

Model Number 418000650

Device Problems Component or Accessory Incompatibility (2897); Connection Problem (2900)

Patient Problem Pain (1994)

Event Date 07/11/2015

Event Type  malfunction  

Manufacturer Narrative

User attempted to connect reservoir/pump from lot prior to design change to a regulator made after design change.The user says that the only way to connect these parts is to omit the regulator (de-attach the regulator from the catheter and subsequently attach the reservoir directly to catheter).It is very clearly described in the ifu, that the regulator must never be by-passed and the flow rate shall be verified after applying the reservoir to the regulator.In conclusion, even though the user intended to use incompatible devices, the user adhered to the ifu and used the device as intended e.G.Did not connect the reservoir directly to the catheter.Additional info was received from the hospital, confirming that the device did not contribute to a death or serious injury.

Event Description

Patient had bilateral paravertebral nerve block placed three days prior during a nuss procedure.Medical team attempt to extend the pain therapy by replacing the empty local anesthetic reservoir with another pre-filled reservoir.The exit connector of the new pre-filled reservoir wasn't compatible with the pumps' regulating set inlet port connector; therefore couldn't be connected.As a result, the pain therapy couldn't be extended.

• Brand Name: ACTION BLOCK
• Type of Device: PUMP, INFUSION PUMP, ELASTOMERIC
• Manufacturer (Section D): MEDICAL FLOW SYSTEMS LTD; elt building dora industrial zone; p.o. box 26; shlomi, ha zafon 22832 00; IS 2283200
• Manufacturer (Section G): MEDICAL FLOW SYSTEMS LTD; elt building dora industrial zone; p.o. box 26; shlomi, ha zafon 22832 00; IS 2283200
• Manufacturer Contact: ofer shay ; elt building dora industrial zone; p.o. box 26; shlomi, ha zafon 22832-00 ; IS 2283200 ; 049114876
• MDR Report Key: 5260738
• MDR Text Key: 32708478
• Report Number: 3006540380-2015-00001
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 418000650
• Device Catalogue Number: 418000650
• Device Lot Number: 16940801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2014
• 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