MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0479-53

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Device not accessible for testing: (4117/213) at this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event.There has been communication with the customer and the pump was not removed from service.A supplemental report will be submitted when this information is provided to us.(b)(6).

Event Description

It was reported that while trouble shooting an iab catheter alarm "leak in iab circuit" x 3 and "optical sensor failure" on cs300 intra-aortic balloon pump (iabp).A decision made to remove and replace catheter with new catheter and pump changed without incident.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Corrected fields: d4 (version, catalog , unique identifier- unknown ), h3, h4.Additional information was requested from the fse with regard to the repair and status of the iabp; however, despite our best efforts, no repair information and no status of the iabp has been received.If any pertinent information is received in the future, a supplemental report will be submitted.H3 other text : device repair status unknown.

• Brand Name: CS300
• 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: 12204557
• MDR Text Key: 262711545
• Report Number: 2249723-2021-01583
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

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: 0998-00-0479-53
• Device Catalogue Number: 0998-00-0479-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2002
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 76 KG