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 Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

Communication/interviews: a getinge clinical specialist conversed with the customer and at first it appeared the issue might have been with the cs300 iabp.After discussing the situation with the customer, it was also stated that switching out units did not resolve the issue.Apparently, the issue was resolved when the iab was replaced still using the first cs300.A supplemental report will be submitted upon completion of our investigation.The full event site name is (b)(6).

Event Description

It was reported that a sensation plus iab (iab) catheter, 40cc, 7.5 fr was inserted into a patient with a stemi connected to a cs300 intra-aortic balloon pump (iabp); however, there was no pressure waveform or arterial pressure captured on the iabp unit.It was also reported that a second iabp was used and the issue still occurred.It was further reported that a second and same sized iab was inserted and the pressure waveform was captured.After the patient was stabilized, she was transferred to the county medical center for additional treatment.The first iab was discarded.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Additional information was requested from the customer 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.Repair is not done by getinge.

• 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: 14103847
• MDR Text Key: 290571168
• Report Number: 2249723-2022-00832
• 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: 02/27/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS IAB CATHETER, 40CC, 7.5 FR
• Patient Age: 69 YR
• Patient Sex: Female