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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. It was reported that there was no inference of a pump problem given by the customer. The balloon was placed in an off-label method; therefore, the fiber-optic mechanism did not work correctly. The user made an error when attempting to aspirate the fluid lumen of the balloon and allowed air to enter the system. This led to a long period of balloon immobility,as they worked to remedy the situation. The customer affirmed that there is no way they can identify the pump used in the event and the balloon has been discarded. Since there was no reported malfunction of the iabp, no further evaluation is required. If additional information is provided, a supplemental report will be submitted accordingly.
 
Event Description
It was reported that during therapy using an unspecified intra-aortic balloon pump (iabp) and a unknown iab catheter via axillary approach (off-label use), the iabp unit displayed a sensor failure alarm. It was further reported that when switching to use the fluid lumen, the nurse could not aspirate the lumen clean and got air into the flush tubing. The nurse then had to clamp the tubing. When the balloon was being removed, a large clot reportedly dislodged and caused the patient to lose pulse in one arm. The clot was surgically removed and there was no lasting effect for the patient. The customer did not provide the model name or serial number of the iabp in use during this event. In addition, there was no reported malfunction of the involved iabp. The iab used during this event was reported under mfg report number 2248146-2019-00700.
 
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Brand NameUNKNOWN
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 Key8925954
MDR Text Key155500923
Report Number2249723-2019-01349
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated by Manufacturer? No
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: 08/23/2019 Patient Sequence Number: 1
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