MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-62

Device Problem Device Contamination with Body Fluid (2317)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Type of investigation not yet determined : the customer has been presented with a quote for the cost estimate for repairs. Additional information is being requested with regards to the patient complication. Additionally, a report of user error was provided and we are seeking additional clarification. A supplemental report will be submitted upon completion of our investigation or if additional information is provided.

Event Description

It was reported by the customer that the cs300 intra-aortic balloon pump (iabp) unit had blood backed all the way through the tubing and potentially into the machine. It was reported that the patient had a complication that was not due to the cs300 device.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13536784
• MDR Text Key: 285637371
• Report Number: 2249723-2022-00302
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-3023-62
• Device Catalogue Number: 0998-00-3023-62
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 02/15/2022 Patient Sequence Number: 1