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

Catalog Number 0998-00-3023-53

Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 11/17/2016

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for the iabp involved in the event was reviewed.There were no non conformances noted in the dhr related to the reported event.The company service representative evaluated the unit and reported: could not reproduce the reported electrical test fails code #58 ("power-up vent test failed").However, when reviewing the fault/diagnostics logs it was found that the k6 (valve) on the drive manifold would work intermittently.It would open partially, not at all or would open fully during the pneumatic system tests.After replacing the drive manifold the cs300 passed all functional and safety tests to factory specifications.

Event Description

Company representative reported: cath lab tech called reporting that they had just inserted an iab and the cs300 would not pump.The alarm messages were electrical failure #58 ("power-up vent test failed"), maintenance code #3 ("balloon transducer offset failure"), and "autofill failure".Troubleshooting found no evidence of blood in the catheter and all connections were secure using the correct extension tubing.The helium tank was open and there was a full tank icon.Rebooting the pump did not eliminate the alarm messages.I had him disconnect the tubing from the safety disc and perform 3 depressions of the iab fill key.Reconnected to the catheter all the alarms were the same.No other console is available at this facility.I asked him to pursue obtaining another console from an area hospital.They had replaced the initial balloon prior to calling us.Last, during a follow up call by the local company representative who spoke with the customer a few minutes later, the customer reported the patient had expired.

Manufacturer Narrative

The replaced part/component, drive manifold (part number 0104-00-0018_d; s/n: (b)(4)) was returned to the manufacturing facility for further evaluation.The visual inspection of the returned drive manifold did not reveal any damage to the component.Further, additional testing of the returned drive manifold was performed and it was found that the drive manifold would fail the k6 valve activation test.Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.

Event Description

Company representative reported: cath lab tech called reporting that they had just inserted an iab and the cs300 would not pump.The alarm messages were electrical failure #58 ("power-up vent test failed"), maintenance code #3 ("balloon transducer offset failure"), and "autofill failure".Troubleshooting found no evidence of blood in the catheter and all connections were secure using the correct extension tubing.The helium tank was open and there was a full tank icon.Rebooting the pump did not eliminate the alarm messages.I had him disconnect the tubing from the safety disc and perform 3 depressions of the iab fill key.Reconnected to the catheter all the alarms were the same.No other console is available at this facility.I asked him to pursue obtaining another console from an area hospital.They had replaced the initial balloon prior to calling us.Last, during a follow up call by the local company representative who spoke with the customer a few minutes later, the customer reported the patient had expired.

• Brand Name: CS300
• 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: 6166395
• MDR Text Key: 62130269
• Report Number: 2249723-2016-00037
• Device Sequence Number: 0
• Product Code: DSP
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3023-53
• Other Device ID Number: SI161052F9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/12/2017
• Date Device Manufactured: 07/06/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR