MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) evaluated the iabp and powered on the unit, connected test catheter and patient simulator and began pumping without any issue.The stm did notice the helium was low and received a low helium alarm but the unit continued pumping the catheter.The stm checked the fault logs and noticed 2 logged failures: autofill failure #37 0x5 which states "fill fail - shuttle purge timeout iab disconnected or a bad atmospheric calibration- poor vacuum performance.Bad k11, k3, k4, or k10 not closing, pinched tubing from vacuum reservoir." -the stm completed the transducer calibration and vacuum/drive pressure calibrations without any issue.Pneumatic critical failure 124 0x10 which states "solenoid connection test fail pneumatic connection test during startup.Helium fill and nafion flush lines are crossed." -the stm verified the helium and nafion lines were connected properly.The stm performed the pneumatic test and the unit failed during the patient interface module tests.The stm attempted to re-seat the safety disk and pim module and the test continued to fail.The stm replaced the patient interface module and the pneumatic tests are now passing.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.

Event Description

It was reported that during patient transport via helicopter, and after patient was already moved to the helicopter, the cardiosave rescue intra aortic balloon pump (iabp) made a "honking" sound and had a balloon fill error.The customer checked the helium level and drive line which were all good without any issues.The pump was also getting good signal from the ecg and artline.The customer attempted to restart the unit and the bottom "balloon pressure" wave form did not deviate from a flat line.The customer subsequently attempted to pull out all of the lines and put them back, without avail.After the customer attempted to reboot the pump, the unit restarted as normal.However, once the customer hit the start button the machine started to squeal and the screen froze.The customer attempted to reboot the unit three more times, without avail.The customer reported that the patient was connected to the maquet balloon, specifically to a 40cc linear balloon and 7.5fr catheter, for approximately 30 minutes before the device failed.As such, the patient was stable and not harmed nor injured, and no adverse event was reported.

• Brand Name: CARDIOSAVE RESCUE
• 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: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 10765491
• MDR Text Key: 214590620
• Report Number: 2249723-2020-01806
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: 10607567108407
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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