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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 N/A
Device Problems Device Contamination with Body Fluid (2317); Moisture or Humidity Problem (2986)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. Additional information has been requested and a supplemental report will be submitted if subsequent information is provided. (b)(6). Device evaluated by manufacturer? not returned to manufacturer.
 
Event Description
The following report was received via medwatch#: (b)(4). Event date: (b)(6) 2017. It was reported during cardiosave intra-aortic balloon (iab) therapy on a patient who was awaiting heart transplant, the bedside registered nurse (rn) noticed that the waveform on the iabp changed. The rn flushed the line and waveform returned momentarily. The waveform changed again and when the rn assessed the helium tubing, condensation and small specks of blood were found in the line. The coronary care unit team (ccu) was called to the bedside and at this time the amount of blood in the tubing increased. The iabp was put on standby and the helium tubing clamped. The patient reported pain and the cardiothoracic (ct) surgery team came to assess the patient. The intra aortic balloon catheter (iabc) was removed and the patient underwent right axillary artery repair. Please refer to mfg report number 2248146-2019-00894 for information on the involved iabc.
 
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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 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9386318
MDR Text Key168302147
Report Number2249723-2019-01924
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 other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
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 Received03/10/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/28/2017
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: 11/27/2019 Patient Sequence Number: 1
Treatment
INTRA-AORTIC BALLOON CATHETER
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