MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problems Inability to Auto-Fill (1044); Pumping Stopped (1503); Failure to Sense (1559); Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

The full name of the event site in block e1 was shortened due to field character limit; the full name is (b)(6).Upon call back with the nurse, the pump was powered on, but they were unable to press any button that will "make anything happen".Autofill button wouldn't engage, and the resume (start) would not engage.They were able to press a few buttons that did work on the pump.Advised nurse to power down and reboot again, but this did not resolve the issue.At this point, the iab been immobile for at least 45 minutes.They were advised that it is not recommended to resume pumping having been immobile for so long.At first had suggested another pump, but recommended removing the iab and/or replacing, and also consider a new pump.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.No service requested.

Event Description

It was reported that during intra-aortic balloon pump (iabp) therapy, the nurse called from the icu to report that the cs 300 iabp was disconnected from the outlet power for a trip to the ct scanner.After about one minute it was reported that the screen went blank and the iabp stopped.The customer was not sure if it had completely shut down.They rebooted and were able to power it back up, but they were unable to press start and autofill.The iabp then generated an autofill failure message as well as a low vacuum message.The autofill button and start button would not engage.They were able to press a few buttons that did work on the iabp.The getinge representative advised to power down and reboot again, but this did not resolve the issue.The getinge representative recommended replacing the iabp and/or removing/replacing the intra-aortic balloon catheter due to it being immobile for at least 45 minutes.The physician was to be called for determination of the next steps.There was no patient harm or adverse event reported.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14237684
• MDR Text Key: 290467702
• Report Number: 2249723-2022-00949
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2001
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50CC CATHETER
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 136 KG