MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Device Alarm System (1012); No Audible Alarm (1019); No Display/Image (1183); Pumping Stopped (1503); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that the nursing staff noticed that during use on a patient, the screen of the cs300 intra-aortic balloon pump (iabp) was totally black.Upon further investigation, it was noted that the iabp was not pumping and was totally silent; no alarms occurred.The mains power cables were quickly checked and found to be plugged in and were turned on.The small top left hand on/off switch on the pump was then turned off for two (2) seconds and back on again.At that point it was noted that the patients¿ blood pressure was dropping.Fortunately, the iabp restarted and the nursing staff ensured the iabp was pumping again using the keypad.It was reported that upon restart, there were no technical alarms or any indication as to why the incident may have occurred.The iabp then ran for approximately two (2) more hours with no further incident.To avoid reoccurrence, about 10 minutes after the pump had been restarted, the nursing staff rechecked the surrounding area of the bedside to try and find a cause.As part of the rechecking process, the nursing staff disconnected the mains power for a short time so that they could see the battery remaining indicator, in order to check the battery level on the unit.The batteries indicated full charge.This brief power disconnection at the time of the event was reflected in the battery statistics log.Following the event, the facility¿s biomedical engineer visited the icu and did not see any issues with the pump; the iabp was running normally on the patient.The biomed noted the hour meter reading on the pump, the fan was running and the air coming from the fan was only warm.There was nothing untoward and nothing further the biomed could do with the pump.The patient was awaiting transfer to another facility (hobart) for further planned treatment.At the suggestion of the biomed, the cs300 iabp from st vincent¿s hospital was borrowed instead and the patient was transferred via road ambulance using the alternative borrowed pump.After the patient had been removed from the suspected pump, the biomed retrieved as much service data from the service menus as possible and provided screenshots.The biomed ran a safety disk test and testing passed ok.The biomed reported that it appeared to him that at the time of the failure, no errors were recorded in the logs by the iabp unit.The biomed expressed concern of no errors being recorded, no alarms sounded and the pump silently switching itself off; putting the patient in jeopardy.The biomed requested that the iabp unit be looked at by the manufacturer to find out the root cause of the event.It was reported by the hospital that the patient became hypotensive when the iabp failed.The iabp was restarted and the patient's blood pressure recovered.No further adverse event of the patient was reported.The report for the involved iab has been submitted under mfg report #2248146-2019-00295.

Event Description

It was reported that the nursing staff noticed that during use on a patient, the screen of the cs300 intra-aortic balloon pump (iabp) was totally black.Upon further investigation, it was noted that the iabp was not pumping and was totally silent; no alarms occurred.The mains power cables were quickly checked and found to be plugged in and were turned on.The small top left hand on/off switch on the pump was then turned off for two (2) seconds and back on again.At that point it was noted that the patients¿ blood pressure was dropping.Fortunately, the iabp restarted and the nursing staff ensured the iabp was pumping again using the keypad.It was reported that upon restart, there were no technical alarms or any indication as to why the incident may have occurred.The iabp then ran for approximately two (2) more hours with no further incident.To avoid reoccurrence, about 10 minutes after the pump had been restarted, the nursing staff rechecked the surrounding area of the bedside to try and find a cause.As part of the rechecking process, the nursing staff disconnected the mains power for a short time so that they could see the battery remaining indicator, in order to check the battery level on the unit.The batteries indicated full charge.This brief power disconnection at the time of the event was reflected in the battery statistics log.Following the event, the facility¿s biomedical engineer visited the icu and did not see any issues with the pump; the iabp was running normally on the patient.The biomed noted the hour meter reading on the pump, the fan was running and the air coming from the fan was only warm.There was nothing untoward and nothing further the biomed could do with the pump.The patient was awaiting transfer to another facility (hobart) for further planned treatment.At the suggestion of the biomed, the cs300 iabp from (b)(6) hospital was borrowed instead and the patient was transferred via road ambulance using the alternative borrowed pump.After the patient had been removed from the suspected pump, the biomed retrieved as much service data from the service menus as possible and provided screenshots.The biomed ran a safety disk test and testing passed ok.The biomed reported that it appeared to him that at the time of the failure, no errors were recorded in the logs by the iabp unit.The biomed expressed concern of no errors being recorded, no alarms sounded and the pump silently switching itself off; putting the patient in jeopardy.The biomed requested that the iabp unit be looked at by the manufacturer to find out the root cause of the event.It was reported by the hospital that the patient became hypotensive when the iabp failed.The iabp was restarted and the patient's blood pressure recovered.No further adverse event of the patient was reported.The report for the involved iab has been submitted under mfg report #2248146-2019-00295.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit to find a reason for the reported shutdown during use.The fse replaced the solenoid driver board and power supply assembly (components from trade-in units that were from the getinge brisbane office) as part of the checking/testing process.No problems were found during the system testing.The fse was unable to reproduce the reported issue.The fse carried out parts replacement followed by a preventative maintenance (pm).The iabp unit is currently in the possesion of the customer undergoing testing.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that the nursing staff noticed that during use on a patient, the screen of the cs300 intra-aortic balloon pump (iabp) was totally black.Upon further investigation, it was noted that the iabp was not pumping and was totally silent; no alarms occurred.The mains power cables were quickly checked and found to be plugged in and were turned on.The small top left hand on/off switch on the pump was then turned off for two (2) seconds and back on again.At that point it was noted that the patients¿ blood pressure was dropping.Fortunately, the iabp restarted and the nursing staff ensured the iabp was pumping again using the keypad.It was reported that upon restart, there were no technical alarms or any indication as to why the incident may have occurred.The iabp then ran for approximately two (2) more hours with no further incident.To avoid reoccurrence, about 10 minutes after the pump had been restarted, the nursing staff rechecked the surrounding area of the bedside to try and find a cause.As part of the rechecking process, the nursing staff disconnected the mains power for a short time so that they could see the battery remaining indicator, in order to check the battery level on the unit.The batteries indicated full charge.This brief power disconnection at the time of the event was reflected in the battery statistics log.Following the event, the facility¿s biomedical engineer visited the icu and did not see any issues with the pump; the iabp was running normally on the patient.The biomed noted the hour meter reading on the pump, the fan was running and the air coming from the fan was only warm.There was nothing untoward and nothing further the biomed could do with the pump.The patient was awaiting transfer to another facility (hobart) for further planned treatment.At the suggestion of the biomed, the cs300 iabp from st vincent¿s hospital was borrowed instead and the patient was transferred via road ambulance using the alternative borrowed pump.After the patient had been removed from the suspected pump, the biomed retrieved as much service data from the service menus as possible and provided screenshots.The biomed ran a safety disk test and testing passed ok.The biomed reported that it appeared to him that at the time of the failure, no errors were recorded in the logs by the iabp unit.The biomed expressed concern of no errors being recorded, no alarms sounded and the pump silently switching itself off; putting the patient in jeopardy.The biomed requested that the iabp unit be looked at by the manufacturer to find out the root cause of the event.It was reported by the hospital that the patient became hypotensive when the iabp failed.The iabp was restarted and the patient's blood pressure recovered.No further adverse event of the patient was reported.The report for the involved iab has been submitted under mfg report #2248146-2019-00295.

Manufacturer Narrative

It was reported that the customer has completed the on-site testing of the cs300 iabp and returned the unit to clinical use.It was clarified that the power supply and solenoid board were permanently replaced.The getinge field service engineer (fse) replaced both parts at one time in order to resolve the intermittent problem as soon as possible.Back at the getinge office, the fse installed the solenoid driver board into another iabp for testing purposes.The iabp turned itself off in 12.5 hours; thus, the fse confirmed that the solenoid driver board was faulty.The suspected board will be returned to the getinge national repair center (nrc) for further investigation.A supplemental report will be submitted when additional information is made available.

Manufacturer Narrative

The suspected faulty solenoid driver board was received at the getinge national repair center (nrc).A senior repair technician of the nrc inspected the board and no visual damage was observed.The technician installed the solenoid driver board into the cs300 test fixture and tested to factory specifications per cs300 service manual.Testing passed and the reported failure of ¿system shutting off without warning¿ could not be verified.The solenoid driver board will be sent to the supplier for further analysis per procedure.A supplemental report will be submitted when additional information is made available.

Event Description

It was reported that the nursing staff noticed that during use on a patient, the screen of the cs300 intra-aortic balloon pump (iabp) was totally black.Upon further investigation, it was noted that the iabp was not pumping and was totally silent; no alarms occurred.The mains power cables were quickly checked and found to be plugged in and were turned on.The small top left hand on/off switch on the pump was then turned off for two (2) seconds and back on again.At that point it was noted that the patients¿ blood pressure was dropping.Fortunately, the iabp restarted and the nursing staff ensured the iabp was pumping again using the keypad.It was reported that upon restart, there were no technical alarms or any indication as to why the incident may have occurred.The iabp then ran for approximately two (2) more hours with no further incident.To avoid reoccurrence, about 10 minutes after the pump had been restarted, the nursing staff rechecked the surrounding area of the bedside to try and find a cause.As part of the rechecking process, the nursing staff disconnected the mains power for a short time so that they could see the battery remaining indicator, in order to check the battery level on the unit.The batteries indicated full charge.This brief power disconnection at the time of the event was reflected in the battery statistics log.Following the event, the facility¿s biomedical engineer visited the icu and did not see any issues with the pump; the iabp was running normally on the patient.The biomed noted the hour meter reading on the pump, the fan was running and the air coming from the fan was only warm.There was nothing untoward and nothing further the biomed could do with the pump.The patient was awaiting transfer to another facility (hobart) for further planned treatment.At the suggestion of the biomed, the cs300 iabp from st vincent¿s hospital was borrowed instead and the patient was transferred via road ambulance using the alternative borrowed pump.After the patient had been removed from the suspected pump, the biomed retrieved as much service data from the service menus as possible and provided screenshots.The biomed ran a safety disk test and testing passed ok.The biomed reported that it appeared to him that at the time of the failure, no errors were recorded in the logs by the iabp unit.The biomed expressed concern of no errors being recorded, no alarms sounded and the pump silently switching itself off; putting the patient in jeopardy.The biomed requested that the iabp unit be looked at by the manufacturer to find out the root cause of the event.It was reported by the hospital that the patient became hypotensive when the iabp failed.The iabp was restarted and the patient's blood pressure recovered.No further adverse event of the patient was reported.The report for the involved iab has been submitted under mfg report #2248146-2019-00295.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (evaluation result & conclusion codes), h10.The supplier evaluated the solenoid driver board and reported that they could not verify the reported failure of system shutting off without warning.The solenoid driver board passed all of their testing.The board was returned to the getinge national repair center (nrc).A senior repair technician of the nrc installed the solenoid driver board into the cs300 test fixture and tested to factory specifications per cs300 service manual.The board passed testing.The solenoid driver board has been scrapped and will be retained in the nrc per procedure.

Event Description

It was reported that the nursing staff noticed that during use on a patient, the screen of the cs300 intra-aortic balloon pump (iabp) was totally black.Upon further investigation, it was noted that the iabp was not pumping and was totally silent; no alarms occurred.The mains power cables were quickly checked and found to be plugged in and were turned on.The small top left hand on/off switch on the pump was then turned off for two (2) seconds and back on again.At that point it was noted that the patients¿ blood pressure was dropping.Fortunately, the iabp restarted and the nursing staff ensured the iabp was pumping again using the keypad.It was reported that upon restart, there were no technical alarms or any indication as to why the incident may have occurred.The iabp then ran for approximately two (2) more hours with no further incident.To avoid reoccurrence, about 10 minutes after the pump had been restarted, the nursing staff rechecked the surrounding area of the bedside to try and find a cause.As part of the rechecking process, the nursing staff disconnected the mains power for a short time so that they could see the battery remaining indicator, in order to check the battery level on the unit.The batteries indicated full charge.This brief power disconnection at the time of the event was reflected in the battery statistics log.Following the event, the facility¿s biomedical engineer visited the icu and did not see any issues with the pump; the iabp was running normally on the patient.The biomed noted the hour meter reading on the pump, the fan was running and the air coming from the fan was only warm.There was nothing untoward and nothing further the biomed could do with the pump.The patient was awaiting transfer to another facility (hobart) for further planned treatment.At the suggestion of the biomed, the cs300 iabp from st vincent¿s hospital was borrowed instead and the patient was transferred via road ambulance using the alternative borrowed pump.After the patient had been removed from the suspected pump, the biomed retrieved as much service data from the service menus as possible and provided screenshots.The biomed ran a safety disk test and testing passed ok.The biomed reported that it appeared to him that at the time of the failure, no errors were recorded in the logs by the iabp unit.The biomed expressed concern of no errors being recorded, no alarms sounded and the pump silently switching itself off; putting the patient in jeopardy.The biomed requested that the iabp unit be looked at by the manufacturer to find out the root cause of the event.It was reported by the hospital that the patient became hypotensive when the iabp failed.The iabp was restarted and the patient's blood pressure recovered.No further adverse event of the patient was reported.The report for the involved iab has been submitted under mfg report #2248146-2019-00295.

Manufacturer Narrative

Corrected field: h6 (conclusion codes).Updated fields: b4, g4, g7, h2, h10, h11.

Event Description

It was reported that the nursing staff noticed that during use on a patient, the screen of the cs300 intra-aortic balloon pump (iabp) was totally black.Upon further investigation, it was noted that the iabp was not pumping and was totally silent; no alarms occurred.The mains power cables were quickly checked and found to be plugged in and were turned on.The small top left hand on/off switch on the pump was then turned off for two (2) seconds and back on again.At that point it was noted that the patients¿ blood pressure was dropping.Fortunately, the iabp restarted and the nursing staff ensured the iabp was pumping again using the keypad.It was reported that upon restart, there were no technical alarms or any indication as to why the incident may have occurred.The iabp then ran for approximately two (2) more hours with no further incident.To avoid reoccurrence, about 10 minutes after the pump had been restarted, the nursing staff rechecked the surrounding area of the bedside to try and find a cause.As part of the rechecking process, the nursing staff disconnected the mains power for a short time so that they could see the battery remaining indicator, in order to check the battery level on the unit.The batteries indicated full charge.This brief power disconnection at the time of the event was reflected in the battery statistics log.Following the event, the facility¿s biomedical engineer visited the icu and did not see any issues with the pump; the iabp was running normally on the patient.The biomed noted the hour meter reading on the pump, the fan was running and the air coming from the fan was only warm.There was nothing untoward and nothing further the biomed could do with the pump.The patient was awaiting transfer to another facility (hobart) for further planned treatment.At the suggestion of the biomed, the cs300 iabp from st vincent¿s hospital was borrowed instead and the patient was transferred via road ambulance using the alternative borrowed pump.After the patient had been removed from the suspected pump, the biomed retrieved as much service data from the service menus as possible and provided screenshots.The biomed ran a safety disk test and testing passed ok.The biomed reported that it appeared to him that at the time of the failure, no errors were recorded in the logs by the iabp unit.The biomed expressed concern of no errors being recorded, no alarms sounded and the pump silently switching itself off; putting the patient in jeopardy.The biomed requested that the iabp unit be looked at by the manufacturer to find out the root cause of the event.It was reported by the hospital that the patient became hypotensive when the iabp failed.The iabp was restarted and the patient's blood pressure recovered.No further adverse event of the patient was reported.The report for the involved iab has been submitted under mfg report #2248146-2019-00295.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8533450
• MDR Text Key: 142599578
• Report Number: 2249723-2019-00641
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 01/28/2020

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: 0998-00-3023-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 04/11/2019; 06/02/2019; 07/11/2019; 09/16/2019; 01/28/2020
• Supplement Dates FDA Received: 05/08/2019; 06/06/2019; 07/26/2019; 09/19/2019; 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR
• Patient Weight: 80