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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/08/2021

Event Type  Death  

Manufacturer Narrative

At the customer's request, a getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and observed alarms for "gas loss" and "triggering issues." the stm performed a complete preventative maintenance (pm) service and ran all functional tests and validated calibration.No issues were found and the iabp unit was cleared for use and returned to the customer.The first name of the initial reporter has been abbreviated due to field character limit; the full name should read (b)(6).The full name of the event site was shortened due to field character limit; the full name is (b)(6) medical center.

Event Description

The customer has requested that the cardiosave intra-aortic balloon pump (iabp) be checked to verify it can run and work properly after it was reported that the intra-aortic balloon (iab) had burst.It was noted that patient therapy was emergently initiated in an attempt to save the patient; however, the patient expired.There was no reported malfunction of the iabp unit involved in this event, and the customer has not attributed the patient death to the iabp unit involved.This report is for the iabp used in the event.The iab is being reported on a separate mdr.

Event Description

N/a.

Manufacturer Narrative

Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data cannot be conducted as no specific failure mode was reported for the product ¿cardiosave¿.Trend analysis: (4110) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.

• 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12101266
• MDR Text Key: 260021460
• Report Number: 2249723-2021-01416
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 7.5FR.
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 51 KG