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

Model Number N/A

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

Patient Problem Death (1802)

Event Date 10/16/2020

Event Type  Death  

Manufacturer Narrative

A getinge service engineer evaluated the iabp unit and after trouble shooting and checking the unit for proper operation he was unable to reproduce the reported issue. No problems found. All calibrations and leak tests were within factory specs. The unit passed all functional and safety tests per factory specifications. Returned unit to the customer and cleared for clinical use.

Event Description

It was reported that during use on a patient, after 12 hours of use without issue prior to going in for surgery, the cardiosave intra-aortic balloon pump (iabp) was placed in semi auto mode, internal trigger, and 1 to 3 frequency during bypass. After the procedure lasting approximately 2. 5 hours, the iabp was placed back into auto mode and frequency placed to 1 to 1. The iabp alarmed "catheter restriction and fiber optic sensor failure". The catheter was replaced but therapy was not able to resume. The iabp was then replaced and therapy continued. It was reported that the patient expired later that same day. The customer does not attribute the patient's death to the iabp. This report is for the first iabp used. The replacement iabp and the two iab catheters used are being reported under separate medical device reports.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10852038
• MDR Text Key: 216611596
• Report Number: 2249723-2020-01920
• Device Sequence Number: 1
• Product Code: DSP
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/17/2020 Patient Sequence Number: 1

Treatment

2 SENSATION PLUS 50CC IAB CATHETERS