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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number CS100
Device Problem Computer Operating System Problem (2898)
Patient Problem Death (1802)
Event Date 05/22/2016
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 in the dhr related to the reported event. The customer elected to evaluate the iabp and no blood was found on the iabp components and no other failure was reported. The iabp is back into service and is providing therapy to another patient without any issues. On the day of the event day the fault logs recorded autofill failures codes that are associated with "blood detected" alarms.
 
Event Description
The customer reported that while the iabp was in use on a patient, the iabp generated a "blood detected" alarm. 20 minutes after the alarm the caregiver rebooted the iabp and the therapy continued without any problems. The caregiver took 20 minutes to reinitiate the therapy because he was trying to confirm there was no kink in the iab tubing or visual blood in the iab circuit. Thirty-six (36) minutes after the iabp was rebooted, the patient died. The customer caregiver (surgeon) is not attributing the patient's death to the pump event, however the hospital's safety management committee believes since the iab therapy was interrupted for 20 minutes, it might have contributed to the patient's death. The customer provided the pre-existent medical history of the patient: the patient was hospitalized in a different hospital under treatment for his leg, details of the disease is unknown. The patient suffered cardiopulmonary arrest twice in the past, and received resuscitation each time. When the patient was transferred to the hospital where the reported event occurred on (b)(6), the patient condition was ventricular fibrillation, and the surgeon was considering icd. On (b)(6) 2016, the patient was in cardiac arrest and was transferred from a different hospital; pcps was started and iab therapy also started. On (b)(6) 2016, pcps was weaned; iab therapy continued and external pacemaker was used. On (b)(6) 2016, the reported event occurred.
 
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Brand NameCS100
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 Key5728963
MDR Text Key47516066
Report Number2249723-2016-00019
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCS100
Device Catalogue Number0998-00-3013-XX
Other Device ID NumberSA06596-E7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received05/30/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/29/2007
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: 06/16/2016 Patient Sequence Number: 1
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