MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problems Restricted Flow rate (1248); Appropriate Term/Code Not Available (3191)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the cardiosave intra-aortic balloon pump (iabp) took off alarm.There were no injuries.

Manufacturer Narrative

Corrected data: b5, e3.Updated data: b4, e1 (email and address), g3, g6, h2, h10, h11.

Event Description

It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) machine notified iab catheter restriction before the warning message iabp may require maintenance.They tried to calibrate (drive regulator : pass).After that the machine worked and did not have the warning message iabp may require maintenance.There were no injuries.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.A getinge field service engineer(fse) evaluated the cardiosave pump.Fse checked the symptoms and a message appears indicating iabp may require maintenance.Initially checked the vacuum regulator and pressure regulator and found that the values were not at normal levels.Therefore, the settings were adjusted again.After adjusting the settings, testing the operation of the machine.Found that it can be used normally.

Event Description

It was reported the cardiosave intra-aortic balloon pump (iabp) machine notified iab catheter restriction before the warning message iabp may require maintenance.They tried to calibrate (drive regulator : pass).After that the machine worked and did not have the warning message iabp may require maintenance.There were no injuries.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 18789451
• MDR Text Key: 336345461
• Report Number: 2249723-2024-00866
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1