• 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 CARDIOSAVE HYBRID TYPE B PLUG 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 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed. There were no non-conformances in the production dhr related to the reported event. A getinge service territory manager (stm) was dispatched to evaluate the iabp unit for the reported balloon rupture. The stm did not observe blood intrusion into the pump and no pump failure was identified. The iabp unit passed all calibration, functional, and safety tests per factory specifications. The unit was returned to the customer and cleared for clinical use. Several attempts have been made to obtain additional information from the customer regarding the patient adverse event. However, despite our best efforts, no response has been provided. If additional information is provided at a later date, a supplemental report will be submitted accordingly.
 
Event Description
It was reported that the intra-aortic balloon (iab) ruptured during patient therapy with the cardiosave intra-aortic balloon pump (iabp). The customer requested that the unit be checked out. There was no reported malfunction of the iabp. No patient information was made available and there was no indication of actual or potential for harm or death. This event was initially documented as a non-reportable event, as there was no reported malfunction of the involved iabp. It was later confirmed with the facility¿s biomedical engineer that this iabp unit may have been in use during or following the adverse event complaint reported under mfg report number 2248146-2019-00641. The customer reported that ¿the catheter was sent with the patient to the coroner¿s office¿. No further information or clarification was provided. There was no reported failure of the iabp and the facility has not attributed the patient death to the iabp unit.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARDIOSAVE HYBRID TYPE B PLUG
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
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9154223
MDR Text Key161164577
Report Number2249723-2019-01586
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 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2018
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: 10/03/2019 Patient Sequence Number: 1
-
-