MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-55

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cs100 intra-aortic balloon pump (iabp)unit had condensation in catheter.There was no harm reported.

Event Description

It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp)unit had condensation in catheter.There was no patient involvement.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse checked the log history which indicated a serious problem, which has been identified as a large amount of water condensation in the safety disk and connecting tubes.The fse also noted other logged faults which occurred when there was a water condensation problem with the balloon pump.The fse also stated that the customer removed the water condensation prior to the service call.The fse then stated that the unit was operated without any unexpected errors.However, the diagnosing logs confirmed the reported event.The fse then checked the electrical connectors of the shuttle and drive transducers at the front end board and removed and installed the connectors several times to confirm a good electrical contact.Then checked the operation of the crm and no problems were found.The fse also mentioned to the customer that if water condensation is seen in the catheter external tubing during use, there is a procedure for the user to remove the condensation - user manual - 3.4 clinical consideration, 3.4.1 water condensation.And, it was implied by the customer that this process is not carried out to his knowledge.Then, it was stated that the customer planned to run the system in a testing state as an extra precaution before returning for clinical use.All functional and safety checks performed to meet factory specifications and the unit was returned to the customer and cleared for clinical use.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 15315232
• MDR Text Key: 305352938
• Report Number: 2249723-2022-02207
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: 10607567107295
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1