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 Device Displays Incorrect Message (2591)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  Injury  

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) units getting persistent gas and circuit alarms.There was no patient harm or injury reported.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) units getting persistent gas and circuit alarms.Patient had a brief vt/vf arrest requiring acls and shock x 2.Afterwards, patient was in a tachycardic rhythm (i don't know which one specifically).Gas loss alarm appeared and iabp stopped pumping.No blood in the gas line, connections were tight.Iabp restarted via start button but would only pump for a few seconds then stop with the gas loss alarm again.It was decided to switch to another iabp machine as blood pressures and patient condition were tenuous.The switch was successful immediately.The patient then went to cath lab to be re-cannulated for va ecmo.

Event Description

N/a.

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 tested the unit and was unable to reproduce the error but the compressor was running hot.The fse then completed a full system test (calibration, functionality, and safety checks), and all tests passed to factory specifications.The fse then ran the unit several hours while onsite and it ran as normal.Then, the fse left the unit pumping overnight and found that there were multiple "tec #77 - increased motor speed required".So, the fse ordered a compressor and, upon receipt, returned to the location to replace it.The fse then completed a full system test / pm protocol, all tests passed to factory specifications.The unit was then returned to the customer and released for clinical use.The fse also stated that the 9v battery was installed in the doppler accessory as a normal maintenance item.

• 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: 15765478
• MDR Text Key: 307300402
• Report Number: 2249723-2022-02907
• 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,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 01/09/2023; 03/30/2023; 10/10/2023
• Supplement Dates FDA Received: 12/06/2022; 01/30/2023; 03/30/2023; 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MEGA 8FR 50 CC IAB CATHETER.; UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 77 KG