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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Gas Leak (2946); Noise, Audible (3273)
Patient Problem Death (1802)
Event Date 08/25/2016
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 company representative was unable to duplicate the reported problem and or observe the failure in the fault logs. The iabp was tested to factory specification. It functioned normally and was returned to the customer.
 
Event Description
The customer reported that while the iabp was in use on a patient, the iabp generated a "gas loss" alarm three times in a 24 hours period. The iab fill was initiated followed by restart. The fittings were checked and the iab catheter was checked for blood migration - no blood migration was observed or reported. The caregiver noted a "hissing" noise coming from the iabp above the battery wells. The company representative advised to replace the iabp. The patient expired however the patient's death is not attributed to the iabp, as per the icu nurse. At the time of the patient's death the iabp was not generating a "gas loss" alarm.
 
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Brand NameCARDIOSAVE
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 Key5967162
MDR Text Key55273541
Report Number2249723-2016-00028
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID NumberCH225047L5
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 Received08/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/21/2016 Patient Sequence Number: 1
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