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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
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.
 
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Brand NameCS300
Type of DeviceSYSTEM, 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 Key6166395
MDR Text Key62130269
Report Number2249723-2016-00037
Device Sequence Number0
Product Code DSP
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
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 Received12/12/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number0998-00-3023-53
Other Device ID NumberSI161052F9
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/06/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/12/2016 Patient Sequence Number: 1
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