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 Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during service repair, the cs300 intra-aortic balloon pump (iabp) unit had a low vacuum alarm.

Event Description

N/a.

Manufacturer Narrative

A getinge (fse) evaluated the unit.Powered device 'on' and unit successfully passed all self-tests.Connected known iab and known system trainer and initiated autofill.Unit completed autofill and continued pumping on ecg trigger at 80bpm for approximately 120 minutes.Unable to reproduce 'leak in circuit' alarm at this time.However, while the unit was pumping, it would intermittently alarm 'low vacuum'.Commenced troubleshooting and discovered average vacuum was not in specifications.Also discovered k6, k6a, k7, and k8 leak test was intermittently failing.Replaced 5000 hour pm kit and replaced drive manifold.Full pm, safety, calibration, and functionality checks passed factory specifications.Allowed unit to continue pumping on ecg trigger at 80bpm for approximately 60 minutes without any alarms or abnormal function occurring.Device is functioning in accordance with factory specifications at this time and is cleared for clinical use.

• 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: 15314840
• MDR Text Key: 305371849
• Report Number: 2249723-2022-02203
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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 Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1