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 High Readings (2459)

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/16/2022

Event Type  Death  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse performed a preliminary exam on the iabp unit to ensure it was working appropriately.The iabp unit was observed to work perfectly with no error codes or alarms logged in the system.As this is a rental unit, the iabp unit was not returned to the customer but would be transported back to the getinge warehouse where a full preventative maintenance (pm) and checkout would be performed at a later date.A supplemental report will be submitted upon completion of our investigation.An additional contact at the event site was provided and is as follows: (b)(6).

Event Description

It was reported that during use on a patient, the rental cs300 intra-aortic balloon pump (iabp) functioned ok; however, the patient expired due to illness.The customer later called back as additional information was received from staff and notes from the patient's chart.The customer reports that the details are not certain and that the nurse caring for the patient was very new with little balloon pump experience.The customer stated that while in use, it was noted that the augmentation suddenly doubled from the low 100's to the 200's.The customer also reported that a nurse practitioner at the bedside at the time noted that the a-line waveform did not match the indices on the iabp unit and there may have been a perception that something wasn't right with the iabp unit.The customer stated that the indices displayed the systolic pressure much higher than it actually was and the patient was switched from iv levophed to iv nitroglycerin to manage the blood pressure.At some pint during treatment, the patient went into cardiac arrest, coded, and expired in the sicu.The patient was post myocardial infarction (mi) in cardiogenic and septic shock.The customer indicated the patient was very sick at the time.There were no reported alarms or message on the iabp unit during this time.The iabp unit was sent to the customer's biomed.The customer has not attributed the patient's death to the device.Patient height: 182cm.The associated intra-aortic balloon (iab) involved in this event has been reported under medwatch 2248146-2022-00289.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.At the customer's request, a getinge field service engineer (fse) evaluated the unit.The fse performed a preliminary exam on the unit and stated that the unit worked perfectly with no error codes or alarms logged in the system.The unit was removed from the customer's facility and was transported to the getinge warehouse.The unit passed all functional and safety testing.The iabp was returned to the customer.

Event Description

N/a.

• 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: 14140291
• MDR Text Key: 289484905
• Report Number: 2249723-2022-00886
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2005
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 89 KG