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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-61
Device Problem Device Contamination with Body Fluid (2317)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888)
Event Date 02/23/2020
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) will be reviewed as soon as it is made available.Additional details have been requested.A supplemental report will be submitted when subsequent information is provided.
 
Event Description
During the continuation of patient therapy using a second cs300 intra aortic balloon pump (iabp) blood was again observed, and according to the description of the users, this time there was a lot of blood / coagulum in the tube system.An attempt was made to remove the catheter in the patient room, which failed.The patient was brought to the operating room (or).The user presumably tore off the catheter in the or and the patient suffered a hemorrhagic shock which probably led to the patient's death.This is for the second iabp which was used to support the patient.The customer has not indicated if the patient's death is attributed to the iabp.Please refer to mfg report number 2248146-2020-00155 for the related intra-aortic balloon catheter.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformities related to the reported event were noted.The customer has now requested getinge to service/repair the unit.We will submit a supplemental report when additional information is made available to us.
 
Event Description
During the continuation of patient therapy using a second cs300 intra aortic balloon pump (iabp) blood was again observed, and according to the description of the users, this time there was a lot of blood / coagulum in the tube system.An attempt was made to remove the catheter in the patient room, which failed.The patient was brought to the operating room (or).The user presumably tore off the catheter in the or and the patient suffered a hemorrhagic shock which probably led to the patient's death.This is for the second iabp which was used to support the patient.The customer has not indicated if the patient's death is attributed to the iabp.Please refer to mfg report number 2248146-2020-00155 for the related intra-aortic balloon catheter.
 
Event Description
During the continuation of patient therapy using a second cs300 intra aortic balloon pump (iabp) blood was again observed, and according to the description of the users, this time there was a lot of blood / coagulum in the tube system.An attempt was made to remove the catheter in the patient room, which failed.The patient was brought to the operating room (or).The user presumably tore off the catheter in the or and the patient suffered a hemorrhagic shock which probably led to the patient's death.This is for the second iabp which was used to support the patient.The customer has not indicated if the patient's death is attributed to the iabp.Please refer to mfg report number 2248146-2020-00155 for the related intra-aortic balloon catheter.
 
Manufacturer Narrative
A getinge field service engineer (fse) has advised that the iabp remains under lock and key in völklingen.However, the fse advised that during assessment, the iabp was opened and it was observed that the inner tube system came into contact with blood.The iabp is out of service and will no longer be repaired and used even when released.No further investigation is required.Updated fields: b4, g4, g7, h2, h3, h6 (evaluation method, result and conclusion codes), h10.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key9867748
MDR Text Key184531745
Report Number2249723-2020-00469
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0998-00-3023-61
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/02/2020
Initial Date FDA Received03/23/2020
Supplement Dates Manufacturer Received05/05/2020
06/08/2020
Supplement Dates FDA Received05/18/2020
06/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MEGA 7.5FR. 40CC (SERIAL # (B)(6)).; MEGA 7.5FR. 40CC (SERIAL # (B)(6)).; MEGA 7.5FR. 40CC (SERIAL # (B)(6)).; MEGA 7.5FR. 40CC (SERIAL # (B)(4))
Patient Outcome(s) Death;
Patient Age76 YR
Patient Weight60
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