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 Leak/Splash (1354)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that before use, the cs300 intra-aortic balloon pump (iabp) unit has a helium leak circuit.There was no patient involved.

Manufacturer Narrative

E1 site name : (b)(6).A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

Manufacturer Narrative

Additional information: tel - (b)(6).It was reported that during use the cs300 intra-aortic balloon pump (iabp) had helium leak.A getinge field service engineer (fse) found defect complained of by the customer of helium leak.Fse stated that fault detected in helium circuit leak and ekg cable excessively worn.All the work performed and eliminated loss of external connections to the crm, fse replacement of ekg cable pneu cmpnt m luer and pneu cmpnt coupling str male.All the calibrations and functional tests completed woth hours of work 3089.Final outcome as repair completed and operational tests carried out with positive results.The fault caused no damage/ inconvenience to operators/patients.Replaced material not available because it was disposed of by the customer.No logs available.No patient involved, fault found in tests before using the device.

• 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: 18779486
• MDR Text Key: 337084762
• Report Number: 2249723-2024-00803
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 02/15/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.