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 Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) was giving an error during an autofill and there was a rust colored liquid coming from the unit.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the iabp, all of the log files were collected, and extensive testing was done to the unit, but the fse was unable to reproduce the reported issue.It was confirmed by the fse that the unit did not have "rust colored liquid", leaking from it.Also, the customer could not give a clear description of the error that had occurred.The unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

• 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: 13308492
• MDR Text Key: 289265306
• Report Number: 2249723-2022-00127
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.