MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Gas/Air Leak (2946)

Patient Problems Pulmonary Embolism (1498); Cardiomyopathy (1764); Myocardial Infarction (1969)

Event Date 02/25/2023

Event Type  Death  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) customer called stating that the patient coded and expired while receiving therapy.Customer was informed to print out a trigger and alarm log so the issue could be discovered.Customer described a gas loss alarm that may have triggered the code.

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) customer called stating that the patient coded and expired while receiving therapy.Customer was unable to describe the events and seemed unclear of the details to review them with me.Stated that rn caring for the patient but would need to call me back.I had customer print out a trigger and alarm log so we would have a record of it.Described a gas loss alarm on the cardiosave that may have triggered the code.Stated that dr.Was running the code and the patient passed rather quickly.Customer verbalized that none of the practitioners attributed the patient passing away due to the gas loss alarm.Also customer stated that dr.And np were running the code and did not attribute the event to the equipment or catheter.

Event Description

N/a.

Manufacturer Narrative

Updated data: e1(email).

Event Description

N/a.

Manufacturer Narrative

Updated fields: h6 (type of investigation, investigation findings, investigation conclusions).A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that the safety disk was expired.The fse then tagged the unit out of service while updating the customer on the expired safety disk and further informed the customer on safety disks being on back-order.So, as a precautionary service the customer was provided with rental options on cs300 available at the local agility office and that the customer was also informed that the safety disk needs to be replaced every 4 years and/or 6,000,000 cycles.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• 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: 16501783
• MDR Text Key: 310866774
• Report Number: 2249723-2023-01392
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB SENSATION PLUS 8FR 50CC.
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 109 KG