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 Suction Problem (2170)

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

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use, the cs300 intra-aortic balloon pump (iabp) gave a low vacuum alarm.The unit was swapped out with another to continue therapy.There was no patient harm reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse verified reported complaint based on data contained within logs.He allowed the unit to run on ecg trigger at 80bpm for approximately 60 minutes and was able to confirm and duplicate reported complaint.He then, commenced troubleshooting and discovered metal shavings within the compressor.The fse replaced the compressor assembly and completed full pm, safety, calibration, and functionality checks.All checks passed to factory specifications.The fse allowed the device to run overnight at 100bpm on internal trigger with known iab.The fse returned to the site and confirmed unit continuously ran for approximately 16 hours without any alarms or abnormal function occurring.The iabp unit was functioning in accordance with factory specifications and was cleared for clinical use.The removed parts were returned to failure analysis and testing for evaluation.The failure analysis and testing technician(fat) installed the pump assembly and hoses into the cs300 test fixture and tested the pump assembly and hoses as per the cs300 service.The fat dept.Could not verify the failure of the pump assembly.(low vacuum) after 3hrs of run time.Retaining the pump assembly and hoses in the fat dept.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: 15108211
• MDR Text Key: 304593578
• Report Number: 2249723-2022-01884
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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: 07/14/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.