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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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device|10: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue. However, the fse found that there were several "gas loss warning" entries in the log files. The unit ran for 24 hours with a test balloon and trainer and did not have any error messages or log entries for that time period; it ran perfectly. When the fse returned onsite, the fse was told that the patient (and existing iab) had been moved to a cs300 iabp and that the cs300 gave the error message "leak in iab circuit". The fse suspected that the issue was with the iab (maquet 50cc mega 8fr). The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. A supplemental report will be submitted upon completion of our investigation. This report is for the cardiosave unit. A separate report will be processed for the cs300 unit. The full name of the event site was shortened due to field character limit; the full name is : (b)(6).
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was leaking water every two hours. It was later reported that the patient was switched to another unit, and specifically a cs300 iabp unit. Additionally and unrelated, it was reported that the second iabp unit gave the error message of "leak in iab circuit. " no patient harm, serious injury or adverse event was reported. This report is for the initial/cardiosave iabp used. The cs300 and the iab catheter used in this event are being reported on separate mdrs.
 
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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
MDR Report Key12723995
MDR Text Key281998602
Report Number2249723-2021-02509
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
Treatment
MAQUET 50CC MEGA 8FR, S/N:(B)(4)
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