MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-53

Device Problem Component Incompatible (1108)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted as the result of a retrospective review conducted in capa (b)(4).A supplemental report will be submitted when the evaluation is completed.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) was received on a transfer patient, the end user needed to change the helium tank but could not close the tank.Getinge tech support trouble shot this issue and it was suspected that the valve knob for the helium tank associated with this pump could potentially be stripped.The end user attempted to use the valve knob from one of st.Mercy louis pumps in the cvicu, however the same problem was experienced.The end user was able to find and use a (b)(6) cs300 pump that had a helium valve knob that was in working order.There was no patient injury or harm and no adverse event was reported.

Manufacturer Narrative

It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) had an helium gasket worn out.Was received on a transfer patient, the end user needed to change the helium tank but could not close the tank.Getinge tech support trouble shot this issue and it was suspected that the valve knob for the helium tank associated with this pump could potentially be stripped.There was no patient injury or harm and no adverse event reported.The biomed team was provided with the product code and advised aware of the issue and consider replacing the item with a new part.Valve knob- helium tank.No further information is available complaint will be closed and in the event new information was to become available, this record will be reopened and updated.No service order available and the third party repaired this unit and there is no relevant repair information available.

Event Description

N/a.

• Brand Name: CS100 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: 16272075
• MDR Text Key: 308676955
• Report Number: 2249723-2023-00791
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.