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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-45
Device Problem Inability to Auto-Fill (1044)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/22/2022
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit alerted an autofill failure.Customer tried to initiate autofill and received same failure.Customer called esp number on pump and spoke to answering service.While waiting for return call the staff ended up moving to impella after non successfully resolving pump issue.Customer reported not seeing any blood in pump but noted that in house biomed thought there was blood in the pump.Biomed noted that there was not blood in the pump but some blood on outside of pump.Patient died but customer noted they did not think this was a result of the balloon pump failure.
 
Manufacturer Narrative
A getinge service tech was not called and it was also stated that service was done by in-house biomed.Attempts were made to obtain the additional information regarding the repair of the unit.However, there was no response from the customer.
 
Event Description
N/a.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE I PLUG
Type of Device
SYSTEM, 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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key15769954
MDR Text Key303396914
Report Number2249723-2022-02917
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108421
UDI-Public10607567108421
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 Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-45
Device Catalogue Number0998-00-0800-45
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
THE LOT NUMBER OF THE CATHETER USED IS 3000123458.
Patient Outcome(s) Death;
Patient Age50 YR
Patient SexFemale
Patient Weight52 KG
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