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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
Model Number N/A
Device Problems Difficult to Insert (1316); Failure to Advance (2524); Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Pulmonary Edema (2020)
Event Date 08/30/2017
Event Type  Death  
Event Description
On (b)(6) 2017, while in use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed due to the intra-aortic balloon (iab) having difficulties upon insertion. It was reported that after intra-aortic balloon (iab) insertion into the right femoral artery was unable to advance. The first iab was removed. The 2nd iab was successfully inserted and left in to treat shock less than 48 hours. The patient experienced on (b)(6) 2017 due to pulmonary edema, edp of 38 mm hg, post pea, post stemi. The customer reported that the patient death was not attributed to the iabp/ iab. Mfg report number 2248146-2017-00619 and 2248146-2017-00412 were opened to address the iab's used.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the serial number was not provided. The reporter name was abbreviated due to the name exceeding maximum characters. The complete name is "sangsuk (suki) sifrit garza". This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab. The customer confirmed that there was no malfunction with the iabp, then performed functional and safety checks to meet factory specifications, and iabp was then released back to clinical use. There was no further information provided.
 
Event Description
On (b)(6) 2017, while in use on a patient, the intra-aortic balloon pump (iabp) alarmed due to the intra-aortic balloon (iab) having difficulties upon insertion. It was reported that after intra-aortic balloon (iab) insertion into the right femoral artery was unable to advance. The first iab was removed. The 2nd iab was successfully inserted and left in to treat shock less than 48 hours. The patient experienced on (b)(6) 2017 due to pulmonary edema, edp of 38 mm hg, post pea, post stemi. The customer reported that the patient death was not attributed to the iabp/ iab. Mfg report number 2248146-2017-00619 and 2248146-2017-00412 were opened to address the iab's used.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7011583
MDR Text Key112768713
Report Number2249723-2017-00763
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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
Type of Report Initial,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
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 Received06/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/08/2017 Patient Sequence Number: 1
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