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

Model Number N/A

Device Problem Overheating of Device (1437)

Patient Problems Tachycardia (2095); No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is provided.

Event Description

It was reported that during use on a patient an overheat alarm occurred on a cardiosave intra-aortic balloon pump (iabp) and pumping was stopped.Patient who started using iabp on (b)(6) 2019 at 13:00, said that at night, hr 130bpm to 150bpm and tachycardia was present and the situation was unstable.At around 6:30 am on the (b)(6), a nurse was treating the patient, and the iabp sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed.He called dr and pressed the start button, but it did not work and contacted clinical engineering and made trial and error.Six minutes later, the power was turned on and off and the start button was pressed to resume pumping.No effect on patients health.V-a ecmo was used.After about 8am, we decided to exchange with cs300 after consulting with day shift staff.A replacement iabp was brought in for cardiosave at 12:00 and checked the situation and exchanged it for the target machine.There was no harm or injury to patient an no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10.

Event Description

It was reported that during use on a patient an overheat alarm occurred on a cardiosave intra-aortic balloon pump (iabp) and pumping was stopped.Patient who started using iabp on (b)(6) 2019 at 13:00, said that at night, hr 130bpm to 150bpm and tachycardia was present and the situation was unstable.At around 6:30 am on the (b)(6), a nurse was treating the patient, and the iabp sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed.He called dr.And pressed the start button, but it did not work and contacted clinical engineering and made trial and error.Six minutes later, the power was turned on and off and the start button was pressed to resume pumping.No effect on patients health.V-a ecmo was used.After about 8am, we decided to exchange with cs300 after consulting with day shift staff.A replacement iabp was brought in for cardiosave at 12:00 and checked the situation and exchanged it for the target machine.The customer has not indicated if the patient¿s tachycardia is attributed to the iabp.

Event Description

It was reported that during use on a patient an overheat alarm occurred on a cardiosave intra-aortic balloon pump (iabp) and pumping was stopped.Patient who started using iabp on (b)(6) 2019 at 13:00, said that at night, hr 130bpm to 150bpm and tachycardia was present and the situation was unstable.At around 6:30 am on the 26th, a nurse was treating the patient, and the iabp sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed.He called dr and pressed the start button, but it did not work and contacted clinical engineering and made trial and error.Six minutes later, the power was turned on and off and the start button was pressed to resume pumping.No effect on patients health.V-a ecmo was used.After about 8am, we decided to exchange with cs300 after consulting with day shift staff.A replacement iabp was brought in for cardiosave at 12:00 and checked the situation and exchanged it for the target machine.The customer has not indicated if the patient¿s tachycardia is attributed to the iabp.

Manufacturer Narrative

We have been advised that this iabp unit was returned to the facility for clinical use on 29 june 2020.

Event Description

It was reported that during use on a patient an overheat alarm occurred on a cardiosave intra-aortic balloon pump (iabp) and pumping was stopped.Patient who started using iabp on (b)(6) 2019 at 13:00, said that at night, hr 130bpm to 150bpm and tachycardia was present and the situation was unstable.At around 6:30 am on the 26th, a nurse was treating the patient, and the iabp sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed.He called dr and pressed the start button, but it did not work and contacted clinical engineering and made trial and error.Six minutes later, the power was turned on and off and the start button was pressed to resume pumping.No effect on patients health.V-a ecmo was used.After about 8am, we decided to exchange with cs300 after consulting with day shift staff.A replacement iabp was brought in for cardiosave at 12:00 and checked the situation and exchanged it for the target machine.The customer has not indicated if the patient¿s tachycardia is attributed to the iabp.

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.Upon further evaluation, the reported event was changed to adverse event and product problem due to patient injury.A supplemental mdr will be submitted when additional information is made available.

Event Description

It was reported that during use on a patient an overheat alarm occurred on a cardiosave intra-aortic balloon pump (iabp) and pumping was stopped.Patient who started using iabp on (b)(6) 2019 at 13:00, said that at night, hr 130bpm to 150bpm and tachycardia was present and the situation was unstable.At around 6:30 am on the 26th, a nurse was treating the patient, and the iabp sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed.He called dr and pressed the start button, but it did not work and contacted clinical engineering and made trial and error.Six minutes later, the power was turned on and off and the start button was pressed to resume pumping.No effect on patients health.V-a ecmo was used.After about 8am, we decided to exchange with cs300 after consulting with day shift staff.A replacement iabp was brought in for cardiosave at 12:00 and checked the situation and exchanged it for the target machine.The customer has not indicated if the patient¿s tachycardia is attributed to the iabp.

Manufacturer Narrative

Additional information was provided by the field service engineer (fse) who performed further evaluation on the unit as follows: in order to determine the cause of the system over temperature issue, running test was performed again.A test optic-fiber iab catheter was connected to this iabp unit and pumping started in semi auto operation mode with ecg signal source setting ecg signal to 180 bpm.During the running test, inflation-deflation timing was adjusted slightly to run up the motor speed of the compressor.Approximately 4 hours after pumping started, the "system over temperature" issue appeared once.The result of the running test was reported to our customer by our fse.No part was replaced during the repair.Additionally, preventive maintenance was performed for this iabp unit and running test was performed with heart rate of 130 bpm for 24 hours several times.It was noted that "system over temperature" alarm was not generated during the running test and there were no anomalies found on the temperature sensor on the scroll compressor, either.The unit was scheduled to be returned to the customer for clinical use.

Event Description

It was reported that during use on a patient an overheat alarm occurred on a cardiosave intra-aortic balloon pump (iabp) and pumping was stopped.Patient who started using iabp on (b)(6) 2019 at 13:00, said that at night, hr 130bpm to 150bpm and tachycardia was present and the situation was unstable.At around 6:30 am on the 26th, a nurse was treating the patient, and the iabp sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed.He called dr and pressed the start button, but it did not work and contacted clinical engineering and made trial and error.Six minutes later, the power was turned on and off and the start button was pressed to resume pumping.No effect on patients health.V-a ecmo was used.After about 8am, we decided to exchange with cs300 after consulting with day shift staff.A replacement iabp was brought in for cardiosave at 12:00 and checked the situation and exchanged it for the target machine.The customer has not indicated if the patient¿s tachycardia is attributed to the iabp.

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm conducted a test to confirm the reported event and was not able to reproduce the reported event.The stm conducted a 24 hour running test with a heart rate (hr) of 120 to 130 beats per minute (bpm).The stm checked to see if there was any abnormal temperate rise within the iabp and found no abnormalities.During normal operation of the iabp, the rotation speed of the compressor motor may increase, causing the temperature inside the compressor to rise.Due to this, an alarm may sound if the alarm ¿system overheat¿ is signaled, causing the pump to stop.Based on the stm¿s testing and results, the unit performed within specifications with no further issues.The stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The unit is currently still under evaluation per the customer's request.A follow-up will be filed once additional information is received.

• 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: 9597963
• MDR Text Key: 191680089
• Report Number: 2249723-2020-00087
• Device Sequence Number: 1
• Product Code: DSP
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other