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

Model Number N/A

Device Problems Failure to Sense (1559); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/25/2020

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 service territory manager (stm) was dispatched to the customer's site.The stm evaluated the iabp and unit began pumping without any alarms or abnormal function occurring.The stm allowed unit to continue pumping without alarms or errors occurring for 60 minutes.The stm confirmed unit triggered from ecg and pressure sources, removed ecg and pressure sources and confirmed alarms functioned correctly.The stm continued troubleshooting and detected several trigger changes from ecg to pressure in the logs on (b)(6) 2020 also detected (2) 'no trigger' alarms and several 'augmentation below limit set' alarms which occurred on (b)(6) 2020.The stm performed full preventative maintenance (pm), calibration, safety, and functionality checks were completed per the service manual.All checks passed as per factory specifications.The stm was unable to replicate reported complaint at this time.The unit is functioning in accordance with factory specifications at this time and device has been released for clinical use.

Event Description

It was reported during a st-elevation myocardial infarction (stemi) of the cardiosave intra-aortic balloon pump (iabp) the patient "coded and chest compressions were initiated." end user stated "we stopped compressions, the patient had an asystole waveform and the pump was still pumping in auto mode.The pump was in auto mode with a pressure trigger.They did not have the ecg leads connected to the pump, thus ecg trigger was not available for use.The patient was asytole and they stopped chest compressions to check for a pulse.She said that the pump continued to pump in a pressure trigger.She asked why the pump would continue pumping if the patient was asystole and they were not providing chest compressions.They did not believe the death was due to the intra aortic balloon pump or intra aortic balloon.A separate report will be submitted for the iab.

Manufacturer Narrative

Updated fields: h6 (evaluation method codes).Corrected fields: h6 (evaluation device codes).

Event Description

It was reported during a st-elevation myocardial infarction (stemi) of the cardiosave intra-aortic balloon pump (iabp) the patient "coded and chest compressions were initiated." end user stated "we stopped compressions, the patient had an asystole waveform and the pump was still pumping in auto mode.The pump was in auto mode with a pressure trigger.They did not have the ecg leads connected to the pump, thus ecg trigger was not available for use.The patient was asytole and they stopped chest compressions to check for a pulse.She said that the pump continued to pump in a pressure trigger.She asked why the pump would continue pumping if the patient was asystole and they were not providing chest compressions.They did not believe the death was due to the intra aortic balloon pump or intra aortic balloon.

• 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
• MDR Report Key: 11064380
• MDR Text Key: 223367283
• Report Number: 2249723-2020-02197
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 0998-00-0800-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SENSATION 7FR 40CC IAB.; SENSATION 7FR 40CC IAB
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 100