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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 03/19/2019
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. We have received no report of an alleged malfunction of the unspecified iabp and have requested additional information. If we receive any pertinent information, we will submit a supplemental report. Not returned to manufacturer.
 
Event Description
It was reported that during intra-aortic balloon pump (iabp) therapy; the iabp alarmed "check iab catheter", and that the intra-aortic balloon catheter (iabc) was replaced, but the patient did not survive. The faulty and defective catheter was put aside. Indications for use of iabp was coronary artery bypass grafting (cabg) procedure. The iabp model is unknown; however, there was no reported or alleged malfunction of the iabp. The facility does not attribute the patient's death to the iabp. Please refer to mfg report number 2248146-2019-00709 and 2248146-2019-00710 for reports on the involved iab catheters.
 
Manufacturer Narrative
An agent of the authorized getinge distributor has advised that the customer owns two cs100 units and that back in december 2018, their engineer inspected both iabps because they were out of order. After inspection, the engineer provided a repair quotation in december 2018 for repair of both units, but the facility opted to do the repairs on their own, then advised that the units were functional, but did not share any repair detail with the distributor. As far as the distributor is aware, no life items or 5000 hrs kit were replaced and the facility has continued to use the units. The distributor has no information on which of the cs100 units was involved in this complaint event. No further information is available.
 
Event Description
It was reported that during cs100 intra-aortic balloon pump (iabp) therapy; the iabp alarmed "check iab catheter", and that the intra-aortic balloon catheter (iabc) was replaced, but the patient did not survive. The faulty and defective catheter was put aside. Indications for use of iabp was coronary artery bypass grafting (cabg) procedure. There was no reported or alleged malfunction of the iabp. The facility does not attribute the patient's death to the iabp. Please refer to mfg report number 2248146-2019-00709 and 2248146-2019-00710 for reports on the involved iab catheters.
 
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Brand NameCS100
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8926348
MDR Text Key155419901
Report Number2249723-2019-01354
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3013-XX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/23/2019 Patient Sequence Number: 1
Treatment
BALLOON CATHETER; BALLOON CATHETER; BALLOON CATHETER
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