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

Model Number 0998-00-0800-53

Device Problem Moisture or Humidity Problem (2986)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.Upon arrival, the fse checked the logs which did not show any reported error.The iabp was tested to autofill and pump and ran flawlessly for 2 days.A condensation removal procedure was performed as well as a system check and all manifold tests passed.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had condensation going into the line.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

After further review, an initial emdr for this complaint was incorrectly submitted.This is a non-reportable complaint with a classification of "other", making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel in your database.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had condensation going into the line.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated sections: b4, b6, b7, d10, e2, e3, g2, g3, g6, h2, h10, h11.Corrected sections: d4, d5.Please disregard previous statement to cancel this report, as this is a reportable event.This report is being submitted as the result of a retrospective review conducted in capa 584165.

Event Description

N/a.

• Brand Name: CARDIOSAVEHYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 11216597
• MDR Text Key: 228701848
• Report Number: 2249723-2021-00136
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/04/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 04/16/2021; 03/27/2023
• Supplement Dates FDA Received: 04/16/2021; 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1