MAUDE Adverse Event Report: DATASCOPE CORP. CS300

Model Number CS300

Device Problems Partial Blockage (1065); Inflation Problem (1310)

Patient Problem Death (1802)

Event Date 09/23/2014

Event Type  Death  

Event Description

It was reported that the helium outflow / fill port on a maquet intra aortic balloon pump device was occluded by a dead end male/female luer lock plug and as a result, the iab would not inflate after being deployed.This plug easily fits into the outflow port.It was not detected until after the balloon was discontinued from the pt and disconnected from the pump itself.It was very difficult to see the plug and it fit snugly onto the end ports as if it belonged there.The pt expired before her death was not caused by this event.When a decision was made to insert an iabp, cpr was already in progress and the pt had been without vital signs for several minutes.(b)(4).

Manufacturer Narrative

The customer verified that the luer plug which was reported to occlude the "helium outflow/ fill port" was actually occluding the "iab catheter extender input port".The customer verified that the luer plug was left in the iabp unit from the safety disk leak test.The safety disk leak test is a pre-use test which the customer is advised to perform as per the cs300 operating instructions manual.The test requires multiple interactions with the operator.Specifically during the course of the test, the operator is requested to plug and unplug the iab catheter extender input port of the safety disk, using the supplied luer plug.The iabp prompts the user at the appropriate times for this action with clear messages "plug disk outlet", "unplug disk outlet", and "system test ok".When the safety disk leak test is complete, the iabp system will automatically enter the normal operating mode for pt therapy.Internal complaint number - (b)(4).The customer biomed determined that the iabp unit did not require any repair after this event.The customer then released the iabp unit for clinical use.The production device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances in the dhr related to the reported event.The cause of this event was user error.This complaint was not confirmed because there has been no indication of any defect/malfunction of the iabp or its components.No further failure investigation of any parts will be initiated as no parts were replaced.

• Brand Name: CS300
• Manufacturer (Section D): DATASCOPE CORP.; mahwah NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4640914
• MDR Text Key: 21176805
• Report Number: 2249723-2015-00010
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS300
• Device Catalogue Number: 0998-00-3023-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 100