MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 02/10/2018

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.The getinge company representative reported that the iabp worked normally during the event; there was no malfunction of the iabp.

Event Description

It was reported that during patient therapy with a cs300 intra-aortic balloon pump (iabp), using ymt30r-01, the patient expired due to bleeding (500cc) from the intra-aortic balloon (iab) insertion area.A blood transfusion was provided.In addition, the patient was provided percutaneous cardiopulmonary support (pcps) and was being applied heparin.The iab was removed as the bleeding did not stop.The event is related iab complaint (b)(4).

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7327991
• MDR Text Key: 102017909
• Report Number: 2249723-2018-00382
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/09/2018
• Date Device Manufactured: 09/22/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: YAMATO PLUS-R 7.5FR. 30CC IAB - (B)(4)
• Patient Outcome(s): Death; Required Intervention