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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number CARDIOSAVE HYBRID
Device Problems No Display/Image (1183); Fluid Leak (1250); Loss of Power (1475)
Patient Problem Insufficient Information (4580)
Event Date 01/21/2022
Event Type  malfunction  
Event Description
The rn was just outside the door and heard an unusual sound. She entered the room and saw the screen had gone black, pump was off and a large puddle was on the floor. Anesthesia was close by to support the patient with medication until a replacement machine could be set up. About 450 of the 500 ml bag spilled onto the back of the machine where the ecg and pressure cables connect and then pooled on the floor. We are guessing that a connection in the transducer tubing came loose and since the heparin was inside a pressure bag at 300mmhg it likely suddenly gushed onto the back of the machine. Machine was brought to clinical engineering for evaluation. Manufacturer field service tech opened the machine and found traces of fluid in several spots inside the machine. It appears fluid reached the power supply board, causing the machine to shut down. See attached photos. The ingress protection rating of this machine is specified as ipx0 (no protection against ingress of water). Power supply board was replaced and unit returned to service. Manufacturer response for intraorrtic balloon pump, datascope (per site reporter). Manufacturer field service tech evaluated and repaired the machine.
 
Event Description
The rn was just outside the door and heard an unusual sound. She entered the room and saw the screen had gone black, pump was off and a large puddle was on the floor. Anesthesia was close by to support the patient with medication until a replacement machine could be set up. About 450 of the 500 ml bag spilled onto the back of the machine where the ecg and pressure cables connect and then pooled on the floor. We are guessing that a connection in the transducer tubing came loose and since the heparin was inside a pressure bag at 300mmhg it likely suddenly gushed onto the back of the machine. Machine was brought to clinical engineering for evaluation. Manufacturer field service tech opened the machine and found traces of fluid in several spots inside the machine. It appears fluid reached the power supply board, causing the machine to shut down. The ingress protection rating of this machine is specified as ipx0 (no protection against ingress of water). Power supply board was replaced and unit returned to service. Manufacturer response for intraorrtic balloon pump, datascope (per site reporter). Manufacturer field service tech evaluated and repaired the machine.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
45 barbour pond drive
wayne NJ 07470
MDR Report Key13591024
MDR Text Key286077363
Report Number13591024
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberCARDIOSAVE HYBRID
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/09/2022
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer02/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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