MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-31

Device Problems Communication or Transmission Problem (2896); Unexpected Shutdown (4019)

Patient Problems Unspecified Heart Problem (4454); Insufficient Information (4580)

Event Date 02/08/2024

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) displayed communication failure error and stop working.The device was reset and started working again.There was no patient harm reported.

Manufacturer Narrative

Corrected data: b1, b5, h1, h6 (clinical and impact code).Updated data: b4, e1 (initial reporter and email), e2, e3, g3, g6, h2, h6(problem code), h10, h11.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed communication failure error and stop working.The device was reset and started working again.The unit then had a sudden shut down overnight with loss of counter pulsation.Temporary (moderate) harm reported.Inotropy requirement increased and patient required fluid for the period of nil augmentation.The customer has decided to decommission this instrument, and it will no longer be used.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed communication failure error and stopped working.The user action guide was reported to be followed and the device was reset and started working again.The iabp was swapped out to contnue therapy.Patient stabilized throughout the morning.A decision was made to remove iabp approx.10hrs after event.Temporary (moderate) harm reported.The timing of the balloon deflation was effected.Inotropy requirement increased and patient required fluid for the period of nil augmentation.The customer has decided to decommission this instrument, and it will no longer be used.

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer (fse) was not dispatched to evaluate the unit.The customer has decided to decommission this instrument, and it will no longer be used.H3 other text : device not returned to manufacturer.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• 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: 18719852
• MDR Text Key: 335530349
• Report Number: 2249723-2024-00696
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention; Required Intervention