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

Model Number N/A

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) has advised that the most recent preventative maintenance performed on this unit was in february 2020.Additionally, the fse evaluated the iabp and observed error code #139 had occurred repeatedly.The pneumatic interface module (pim) and the power management board have been ordered for replacement, and a supplemental report will be submitted when additional information is made available.(b)(6).

Event Description

Getinge received a customer service call about an event that occurred during patient treatment on (b)(6) 2020.Please see information from the customer's email: "this email is to inform you that on this evening ((b)(6)) we did an emergency cardiac case on a patient supported by a cardiosave intra-aortic balloon pump (iabp) device.During the case, my colleague and the nurse heard a ¿poof¿ coming from the machine and when they looked over at the device the screen went blank.As the perfusionist rushed over to the device, she smelled of what seems to be an odor of electronic burning (an overheated circuitry).Everyone in the room was also aware of the smell.She immediately unplugged the device from the patient and the wall and proceeded to remove the device from service and replaced it with another iabp console.This patient was very dependent on the device and luckily it happened just when we were going on cardiopulmonary bypass.This patient did not get harmed but i cannot guarantee the outcomes of the next patient.This is why my team and i constantly stress about the equipment being routinely checked and maintained.Subsequent information provided as follows: iabp maquet linear 7.5fr, 34cc inserted via rfa prior to arrival in operating room.(while transferring on batteries, noticed only a single battery was displayed on the screen.Both batteries checked and properly in place, so unsure why).No error code: following a "poof" sound, the screen went blank and iabp support to the patient ceased (no alarm).Console was turned off and then back on, console didn't go through self test, pretty sure the screen remained blank or could've been showing the maquet symbol (sorry can't remember) and console was alarming (a sustained audible tone), but no error code seen and also noticed a "burnt electrical" smell.Unable to shut off via on/off button so console was unplugged from electrical outlet and everything did shut off then.Defective console was immediately replaced with another console and iabp support to the patient was resumed.This happened just prior to going on cardiopulmonary bypass, so patient was supported.Surgery was completed, and patient was transferred to the icu on iabp support.

Event Description

Getinge received a customer service call about an event that occurred during patient treatment on aug 4th,2020.Please see information from the customer's email: "this email is to inform you that on this evening (august 4th) we did an emergency cardiac case on a patient supported by a cardiosave intra-aortic balloon pump (iabp) device.During the case, my colleague and the nurse heard a ¿poof¿ coming from the machine and when they looked over at the device the screen went blank.As the perfusionist rushed over to the device, she smelled of what seems to be an odor of electronic burning (an overheated circuitry).Everyone in the room was also aware of the smell.She immediately unplugged the device from the patient and the wall and proceeded to remove the device from service and replaced it with another iabp console.This patient was very dependent on the device and luckily it happened just when we were going on cardiopulmonary bypass.This patient did not get harmed but i cannot guarantee the outcomes of the next patient.This is why my team and i constantly stress about the equipment being routinely checked and maintained.Subsequent information provided as follows: iabp maquet linear 7.5fr, 34cc inserted via rfa prior to arrival in or.(while transferring on batteries, noticed only a single battery was displayed on the screen.Both batteries checked and properly in place, so unsure why) no error code: following a "poof" sound, the screen went blank and iabp support to the patient ceased (no alarm).Console was turned off and then back on, console didn't go through self test, pretty sure the screen remained blank or could've been showing the maquet symbol (sorry can't remember) and console was alarming (a sustained audible tone), but no error code seen and also noticed a "burnt electrical" smell.Unable to shut off via on/off button? so console was unplugged from electrical outlet and everything did shut off then.Defective console was immediately replaced with another console and iabp support to the patient was resumed.This happened just prior to going on cardiopulmonary bypass, so patient was supported.Surgery was completed, and patient was transferred to the icu on iabp support.

Manufacturer Narrative

The getinge field service engineer (fse) that evaluated the unit cleaned/disinfected device thoroughly and performed initial assessment of the device to confirm customer complaint.Device produces fault code 118 consistently when powering on (using mains power).Unit is unable to go through boot-up sequence when plugged into mains (screen remains blank with the spinning wheel).When using battery power, the device performs normally.The fault code 118 points to power management board issue.Ordered and replaced power management board.Device is now fully operational when using ac.Performed full system calibration, compressor performance tests, and leak tests to determine any further issues.Pim leak test failed.Pim leak test passes when using a different pim module.Possible defective pim module.Allowed device to pump using cardiosave trainer for 48hrs to monitor for errors/alarms.No alarms or errors.Power management board issue has been resolved.However, the pim leak test in "all manifold test" sequence was still failing, ordered and replaced the pim module and the pim assembly.Performed all manifold, leaks tests and electrical tests and all passed per factory specifications.The iabp was returned to the customer and cleared for clinical use.The suspected faulty parts will be returned to factory for failure analysis.

Manufacturer Narrative

The customer returned the suspect power management board to getinge¿s national repair center (nrc) for evaluation.A senior repair technician evaluated the power management board and no visual damage was observed.The senior repair technician then installed the power management board into cardiosave test fixture s/n (b)(6) and tested to factory specifications per cardiosave service manual.The nrc verified the error code 139 in the fault log which occurred 16 times, which is a communication error between the power management board and the exec processor board.The nrc also observed , when the cardiosave console is installed into the cardiosave cart with ac applied, the console turns on without the on off switch being pressed.The board failed testing.The senior repair technician sent the part to supplier for failure analysis as per procedure.Additionally, the customer returned the suspected pneumatic module assembly to getinge's nrc for evaluation.A senior repair technician installed the pneumatic module assembly into the cardiosave test fixture and tested the module to factory specifications per procedure and per the cardiosave service manual.The pneumatic module assembly failed the leak differential test of the patient interface module test.The pneumatic module assembly will be sent to production for failure analysis per procedure.A supplemental report will be submitted when additional information is provided.

Event Description

Getinge received a customer service call about an event that occurred during patient treatment on (b)(6) 2020.Please see information from the customer's email: "this email is to inform you that on this evening (b)(6) we did an emergency cardiac case on a patient supported by a cardiosave intra-aortic balloon pump (iabp) device.During the case, my colleague and the nurse heard a ¿poof¿ coming from the machine and when they looked over at the device the screen went blank.As the perfusionist rushed over to the device, she smelled of what seems to be an odor of electronic burning (an overheated circuitry).Everyone in the room was also aware of the smell.She immediately unplugged the device from the patient and the wall and proceeded to remove the device from service and replaced it with another iabp console.This patient was very dependent on the device and luckily it happened just when we were going on cardiopulmonary bypass.This patient did not get harmed but i cannot guarantee the outcomes of the next patient.This is why my team and i constantly stress about the equipment being routinely checked and maintained.Subsequent information provided as follows: iabp maquet linear 7.5fr, 34cc inserted via rfa prior to arrival in or.(while transferring on batteries, noticed only a single battery was displayed on the screen.Both batteries checked and properly in place, so unsure why).No error code: following a "poof" sound, the screen went blank and iabp support to the patient ceased (no alarm).Console was turned off and then back on, console didn't go through self test, pretty sure the screen remained blank or could've been showing the maquet symbol (sorry can't remember) and console was alarming (a sustained audible tone), but no error code seen and also noticed a "burnt electrical" smell.Unable to shut off via on/off button? so console was unplugged from electrical outlet and everything did shut off then.Defective console was immediately replaced with another console and iabp support to the patient was resumed.This happened just prior to going on cardiopulmonary bypass, so patient was supported.Surgery was completed, and patient was transferred to the icu on iabp support.

Event Description

Getinge received a customer service call about an event that occurred during patient treatment on (b)(6) 2020.Please see information from the customer's email: "this email is to inform you that on this evening ((b)(6)) we did an emergency cardiac case on a patient supported by a cardiosave intra-aortic balloon pump (iabp) device.During the case, my colleague and the nurse heard a ¿poof¿ coming from the machine and when they looked over at the device the screen went blank.As the perfusionist rushed over to the device, she smelled of what seems to be an odor of electronic burning (an overheated circuitry).Everyone in the room was also aware of the smell.She immediately unplugged the device from the patient and the wall and proceeded to remove the device from service and replaced it with another iabp console.This patient was very dependent on the device and luckily it happened just when we were going on cardiopulmonary bypass.This patient did not get harmed but i cannot guarantee the outcomes of the next patient.This is why my team and i constantly stress about the equipment being routinely checked and maintained.Subsequent information provided as follows: iabp maquet linear 7.5fr, 34cc inserted via rfa prior to arrival in operating room.(while transferring on batteries, noticed only a single battery was displayed on the screen.Both batteries checked and properly in place, so unsure why).No error code: following a "poof" sound, the screen went blank and iabp support to the patient ceased (no alarm).Console was turned off and then back on, console didn't go through self test, pretty sure the screen remained blank or could've been showing the maquet symbol (sorry can't remember) and console was alarming (a sustained audible tone), but no error code seen and also noticed a "burnt electrical" smell.Unable to shut off via on/off button?? so console was unplugged from electrical outlet and everything did shut off then.Defective console was immediately replaced with another console and iabp support to the patient was resumed.This happened just prior to going on cardiopulmonary bypass, so patient was supported.Surgery was completed, and patient was transferred to the icu on iabp support.

Manufacturer Narrative

The power management board will not be returned to the supplier for failure analysis due to the supplier escatec not having the capability of testing this older version of the board.Root cause would be impossible to determine.The other part on this complaint, the patient module assembly was sent to production for failure analysis.

Manufacturer Narrative

Production verified the failure of a leak in the differential test ,of the patient interface module test.The production department determined that it was a defective pim fill assembly.The national repair center will retain the pnuematic module per procedure.

Event Description

Getinge received a customer service call about an event that occurred during patient treatment on (b)(6) 2020.Please see information from the customer's email: "this email is to inform you that on this evening ((b)(6)) we did an emergency cardiac case on a patient supported by a cardiosave intra-aortic balloon pump (iabp) device.During the case, my colleague and the nurse heard a ¿poof¿ coming from the machine and when they looked over at the device the screen went blank.As the perfusionist rushed over to the device, she smelled of what seems to be an odor of electronic burning (an overheated circuitry).Everyone in the room was also aware of the smell.She immediately unplugged the device from the patient and the wall and proceeded to remove the device from service and replaced it with another iabp console.This patient was very dependent on the device and luckily it happened just when we were going on cardiopulmonary bypass.This patient did not get harmed but i cannot guarantee the outcomes of the next patient.This is why my team and i constantly stress about the equipment being routinely checked and maintained.Subsequent information provided as follows: iabp maquet linear 7.5fr, 34cc inserted via rfa prior to arrival in operating room (or).(while transferring on batteries, noticed only a single battery was displayed on the screen.Both batteries checked and properly in place, so unsure why).No error code: following a "poof" sound, the screen went blank and iabp support to the patient ceased (no alarm).Console was turned off and then back on, console didn't go through self test, pretty sure the screen remained blank or could've been showing the maquet symbol (sorry can't remember) and console was alarming (a sustained audible tone), but no error code seen and also noticed a "burnt electrical" smell.Unable to shut off via on/off button? so console was unplugged from electrical outlet and everything did shut off then.Defective console was immediately replaced with another console and iabp support to the patient was resumed.This happened just prior to going on cardiopulmonary bypass, so patient was supported.Surgery was completed, and patient was transferred to the intensive care unit (icu) on iabp support.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10454543
• MDR Text Key: 204577175
• Report Number: 2249723-2020-01345
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LINEAR 7.5FR, 34CC
• Patient Age: 78 YR
• Patient Weight: 82