MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-3013-55

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Brain Injury (2219)

Event Date 02/09/2018

Event Type  Death  

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 service engineer visited the facility and upon initial evaluation of the iabp could not duplicate the alleged malfunction.The getinge service engineer send the fault logs to tech support and was advised to replace the power supply and the power switch.As of the date of this report the repair has not been completed as the parts are on order.

Event Description

It was reported that a patient began cs100 intra-aortic balloon pump (iabp) therapy on (b)(6) 2018 during an emergency reopen in the intensive care unit (icu).On (b)(6) 2018, as the patient was being readied to go to the theatre it was noted that the iabp was off.The iabp was turned back on and only half of the screen came on.The iabp was then turned off and on again and then the iabp appeared to work.The iabp was not replaced as patient was going to theatre to have the iab removed.It was later reported that the patient expired on (b)(6) 2018.The patient death was not reported to be attributed to the iabp.It was reported that the patient got a supposed clot in the leg with the balloon in and lost his leg above the knee.His cause of death was attributed to hypoxic brain injury given that he had a very low blood pressure during the reopen and even after the balloon was in, despite inotropic support.He also had graft failure listed on the death certificate.

Manufacturer Narrative

The getinge service engineer reported that he completed the repair on (b)(6) by replacing the cable assembly and power supply.The iabp passed all testing and was then released back to the customer.

Event Description

It was reported that a patient began cs100 intra-aortic balloon pump (iabp) therapy on (b)6)2018 during an emergency reopen in the intensive care unit (icu).On (b)(6)2018, as the patient was being readied to go to the theatre it was noted that the iabp was off.The iabp was turned back on and only half of the screen came on.The iabp was then turned off and on again and then the iabp appeared to work.The iabp was not replaced as patient was going to theatre to have the iab removed.It was later reported that the patient expired on (b)(6)2018.The patient death was not reported to be attributed to the iabp.It was reported that the patient got a supposed clot in the leg with the balloon in and lost his leg above the knee.His cause of death was attributed to hypoxic brain injury given that he had a very low blood pressure during the reopen and even after the balloon was in, despite inotropic support.He also had graft failure listed on the death certificate.

Manufacturer Narrative

The replaced cable assembly and power supply were evaluated at the manufacturing facility.No visual damage of the cable assembly was observed.No visual damage of the power supply was observed either.However, when the bottom cover was removed, there was excessive amount of dust build up inside the power supply.The cable assembly was installed into a cs100 test fixture and tested to factory specifications per the service manual.The cable assembly passed testing and the alleged malfunction was not verified.The part is being retained at the manufacturing facility.The power supply was installed into a cs100 test fixture and tested to factory specifications per the service manual.The power supply passed testing and the alleged malfunction was not verified.The power supply is being sent to the supplier for further failure analysis.A supplemental report will be submitted when the results are received by the manufacturing facility.

Event Description

It was reported that a patient began cs100 intra-aortic balloon pump (iabp) therapy on (b)(6) 2018 during an emergency reopen in the intensive care unit (icu).On (b)(6) 2018, as the patient was being readied to go to the theatre it was noted that the iabp was off.The iabp was turned back on and only half of the screen came on.The iabp was then turned off and on again and then the iabp appeared to work.The iabp was not replaced as patient was going to theatre to have the iab removed.It was later reported that the patient expired on (b)(6) 2018.The patient death was not reported to be attributed to the iabp.It was reported that the patient got a supposed clot in the leg with the balloon in and lost his leg above the knee.His cause of death was attributed to hypoxic brain injury given that he had a very low blood pressure during the reopen and even after the balloon was in, despite inotropic support.He also had graft failure listed on the death certificate.

Manufacturer Narrative

The supplier/vendor has performed an analysis on the power supply and was unable to verify the reported failure.The power supply passed a screen power up.It was determined that the power supply needed cleaning, fan update/replacement and an updated printed circuit board (pcb).The pcb that is needed to complete the update would not be available until may 2019.A follow-up report will be submitted when additional information becomes available.

Event Description

It was reported that a patient began cs100 intra-aortic balloon pump (iabp) therapy on (b)(6) 2018 during an emergency reopen in the intensive care unit (icu).On (b)(6) 2018, as the patient was being readied to go to the theatre it was noted that the iabp was off.The iabp was turned back on and only half of the screen came on.The iabp was then turned off and on again and then the iabp appeared to work.The iabp was not replaced as patient was going to theatre to have the iab removed.It was later reported that the patient expired on (b)(6) 2018.The patient death was not reported to be attributed to the iabp.It was reported that the patient got a supposed clot in the leg with the balloon in and lost his leg above the knee.His cause of death was attributed to hypoxic brain injury given that he had a very low blood pressure during the reopen and even after the balloon was in, despite inotropic support.He also had graft failure listed on the death certificate.

Manufacturer Narrative

The supplier reported that in order to get a test result, they needed to repair the ac input section of the supply to get it to power on for a test.It was determined that the original findings at the tech bench of ¿no output¿ was caused by the cr1 rectifier bridge arcing which in turn caused the fuse to open.After fixing this cr1 fail mode, we were able to run the supply on the ate test to get the other data requested.The root cause of the failure has been determined.No further investigation is required.

Event Description

It was reported that a patient began cs100 intra-aortic balloon pump (iabp) therapy on (b)(6) 2018 during an emergency reopen in the intensive care unit (icu).On (b)(6) 2018, as the patient was being readied to go to the theatre it was noted that the iabp was off.The iabp was turned back on and only half of the screen came on.The iabp was then turned off and on again and then the iabp appeared to work.The iabp was not replaced as patient was going to theatre to have the iab removed.It was later reported that the patient expired on (b)(6) 2018.The patient death was not reported to be attributed to the iabp.It was reported that the patient got a supposed clot in the leg with the balloon in and lost his leg above the knee.His cause of death was attributed to hypoxic brain injury given that he had a very low blood pressure during the reopen and even after the balloon was in, despite inotropic support.He also had graft failure listed on the death certificate.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7313126
• MDR Text Key: 101500597
• Report Number: 2249723-2018-00343
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2005
• 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
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 72