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

Model Number N/A

Device Problem Inability to Auto-Fill (1044)

Patient Problem Death (1802)

Event Date 12/19/2019

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) was dispatched to the customer's site.The fse evaluated the iabp and identified that the fault was caused by the patient interface module (pim).The stm replaced the pim/ safety disk assembly and found that the fault could be replicated every time by refitting the faulty pim assembly.The stm then performed all leak tests, functional and safety tests on iabp, which passed per factory specifications.The iabp was returned to customer and cleared for clinical use.However, the iabp has not been put back into service by the hospital perfusion department and the inquest is ongoing.Due to the passage of time from our evaluation of the unit and being made aware of this adverse event, the suspected faulty parts are no longer available for return evaluation at getinge's national repair center, as they were disposed of after the repair.A supplemental report will be submitted if subsequent information is provided.

Event Description

Initially, it was reported to us in (b)(4) 2019 that autofill failure occurred on the cardiosave intra- aortic balloon pump (iabp).A getinge field service engineer evaluated the unit at that time and made necessary repairs.Subsequently, on (b)(4) 2019, it was reported to us that the iabp was implicated in a patient fatality when the fault was first reported in july.However, there was no information about this at the time of the event.The customer also reported that prior to iabp therapy, the patient had profound hypotension on attempting to place the valve with his blood pressure around 50 mmhg.The valve was withdrawn and the iabp was placed to decrease his ischemic burden.However, it is unknown if the customer attributes the patient death to the device and has advised that the event is subject to internal inquest as to whether the device was a contributing factor, but that the death certificate does not cite that it is.Additional information reported by the customer to mhra: on arrival the console was in standby.Alarm message failure to pump.No obstructions noted to helium gas line.Several unsuccessful attempts made to reinstitute counterpulsation.Changed out console and successful counterpulsation reinstituted.Approximately 20 minutes from arriving to changing the console out.On repair noted that the safety disk was faulty following a recent service.The safety disk is a diaphragm that allows the action of compressed and vacuum air to move under controlled conditions.The balloon counter pulsation therapy was interrupted for period of time on a critically ill patient.Please refer to related mfg report number 2248146-2019-00937 on the involved intra-aortic balloon (iab).

• Brand Name: CARDIOSAVE HYBRID TYPE G 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: 9500408
• MDR Text Key: 172184641
• Report Number: 2249723-2019-02068
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• 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: UNKNOWN IAB
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 72