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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 Problems Optical Problem (3001); Pressure Problem (3012)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/03/2021
Event Type  Injury  
Manufacturer Narrative
Device not accessible for testing: the customer has not requested repair service. A supplemental report will be submitted upon receipt of additional information. Not returned to manufacturer.
 
Event Description
It was reported that a balloon was inserted according to the procedure and connected to a cardiosave intra-aortic balloon pump (iabp), but the pressure waveform was not visualized. It was driven by an ecg trigger and operated for a while. The device indicated "light sensor failure". When the patient's condition deteriorated and pcps was introduced, the balloon was removed and another balloon was used. Find out if the balloon sensor was broken. Shortly after iabp therapy started, the patient almost went into cardiac arrest. The patient was placed on pcps. According to the physician, iabp therapy was able to be continued although fiber optic sensor failure occurred, the reported iab catheter was once removed safely from the patient and the patient was treated with pcps for a while. Later on, another iab catheter was inserted in the patient and iabp therapy started again. There were no adverse consequences to the patient noted so far. This is an automated draft translation. If any uncertainty contact the local ssu immediately###: a balloon was inserted according to the procedure and connected to cardiosave, but the pressure waveform was not visualized. It was driven by an ecg trigger and operated for a while. The device indicated "light sensor failure". When the patient's condition deteriorated and pcps was introduced, the balloon was removed and another balloon was used. Find out if the balloon sensor was broken. Shortly after iabp therapy started, the patient almost went into cardiac arrest. The patient was placed on pcps. According to the physician, iabp therapy was able to be continued although fiber optic sensor failure occurred, the reported iab catheter was once removed safely from the patient and the patient was treated with pcps for a while. Later on, another iab catheter was inserted in the patient and iabp therapy started again. There were no adverse consequences to the patient noted so far. Batch #: 3000142837 , iab insertion date: (b)(6) 2021. Gfe 1 response received 10-dec-2021. Refer to communication box below please see the answers to your questions below. There is no information available. Shortly after iabp therapy started. Shortly after iabp therapy started, the patient almost went into cardiac arrest. The patient was placed on pcps. According to the physician, iabp therapy was able to be continued although fiber optic sensor failure occurred, the reported iab catheter was once removed safely from the patient and the patient was treated with pcps for a while. Later on, another iab catheter was inserted in the patient and iabp therapy started again. There were no adverse consequences to the patient noted so far. Not available. The patient specific information (age/date of birth, sex, height, weight) could not be obtained due to hospital policy. Yes.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13152153
MDR Text Key283154094
Report Number2249723-2021-02958
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
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 NOT REQUIRED FOR HARDWARE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/12/2014
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/04/2022 Patient Sequence Number: 1
Treatment
INTRA-AORTIC BALLOON (IAB) TRANSRAY PLUS 35CC
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