• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inability to Auto-Fill (1044); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombus (2101)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted. A getinge therapy specialist has advised that the iabp was isolated and inspected for blood back, no blood was found in the system internals. Also, no blood back alarms were recorded. Operation of the blood back circuitry was verified by performing a blood back test. No damage was found and the iabp is operational and located in clinical engineering department. No further investigation is required. Device not returned to manufacturer.
 
Event Description
It was reported that during cs300 intra-aortic balloon pump (iabp) therapy, intra-aortic balloon (iab) rupture occurred; the iab insertion was via axillary approach and fluoroscopy was used during insertion. The iabp catheter ruptured and required removal. The clot was another complication. In addition, the iabp alarmed autofill failure and blood was observed in the helium tube set. The indication for use of the iabp was bridge to heart transplant due to heart failure. We were later advised that the patient developed a clot and required thrombectomy. There was no reported malfunction of the iabp and the customer has not indicated if the patient's injury is attributed to the iabp. Please refer to related mfg report number 2248146-2020-00252 on the involved intra-aortic balloon (iab).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10148507
MDR Text Key195267665
Report Number2249723-2020-00904
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 Other Health Care Professional
Type of Report Initial
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
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?
Event Location No Information
Date Manufacturer Received05/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/03/2014
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: 06/12/2020 Patient Sequence Number: 1
-
-