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 Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cs300 intra-aortic balloon pump (iabp) unit had a leak in the circuit alarm.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11 corrected fields: h6 (component codes) a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported malfunction.The fse powered the device on, and the unit successfully passed all self-tests.The fse connected an iabp and system trainer and initiated autofill.The unit completed the autofill and continued pumping on ecg trigger at 80 bpm for approximately 120 minutes.While pumping, the unit would intermittently alarm 'low vacuum'.The fse commenced troubleshooting and discovered that the average vacuum was not in specifications.The fse also discovered that the k6, k6a, k7, and k8 leak test was intermittently failing.The fse replaced the 5000 hour pm kit and the drive manifold.The fse performed a full preventive maintenance (pm), safety, calibration, and functionality checks to factory specifications.The fse allowed the unit to continue pumping on ecg trigger at 80 bpm for approximately 60 minutes without any alarms or abnormal function occurring.The iabp was returned to the customer and cleared for clinical use.There is another complaint opened for 'low vacuum alarm'.The following investigation was performed by the technician of the maquet failure analysis and testing dept.(fat) wayne, nj.The failure analysis and testing dept.Received drive manifold with a reported unit failure of leak in circuit alarm.The failure analysis and testing dept., performed a visual inspection of drive manifold, and found the drive manifold to be in good condition.The failure analysis and testing dept.Installed the drive manifold into the cs 300 test fixture and tested the drive manifold to factory specifications per the cs300 service manual.The failure analysis and testing dept.Performed the k6,k6a,k7,k8 leak test.The first time the k6,k6a,k7,k8 leak test passed testing.After running the unit for approximately 25 minutes, the failure analysis and testing dept.Observed a low vacuum alarm, which occurred intermittently.This alarm was also observed by the field service representative.The failure analysis and testing dept.Then repeated the k6,k6a,k7,k8 leak test.The k6,k6a,k7,k8 leak test failed the second time after the cardiosave ran for 25 minutes.The failure analysis and testing dept.Could not replicate the customer complaint of leak in circuit alarm, after extensive run time of the cardiosave.However, the failure analysis and testing dept.Did observe a low vacuum alarm intermittently when the cardiosave was pumping.The drive manifold failed testing.Retaining the drive manifold in the failure analysis and testing department per procedure.

Event Description

N/a.

• 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: 15304545
• MDR Text Key: 305366614
• Report Number: 2249723-2022-02193
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• 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