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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Backflow (1064); Fracture (1260); Material Rupture (1546); Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597); Patient Problem/Medical Problem (2688)
Event Date 01/02/2019
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. To date, there has been no reported malfunction of the involved unknown iabp, and the customer has not requested getinge service in connection with this event. If additional information is provided, a supplemental report will be submitted. (b)(6).
 
Event Description
It was reported that during intra-aortic balloon pump (iabp) therapy, prior to a cabg (coronary artery bypass graft) surgery, the iabp became loud and blood was observed backing up into the tubing. The intra-aortic balloon catheter (iabc) ruptured inside the patient, and the surgeon removed the iabc and placed a new one. Additionally, the next day, the iabp alarmed "check catheter" when in 1:1, but ran without issue on 1:2. The iabp helium tubing was noted to have blood flecks in it; the balloon had ruptured again inside of the patient. The provider attempted to remove the iabp through sheath and the catheter became fractured. The sheath and remaining portion of the catheter were then removed. Subsequently, the patient's blood pressure decreased during manual compression requiring albumin, levophed and dobutamine to be administered. The patient's hemoglobin dropped from 9. 4 to 7. 1 by the following morning, which resulted in the patient requiring 1 unit of prbcs (packed red blood cells). The date of this event is unknown. In addition, the model of the involved iabp was not reported, and there was also no reported malfunction of the iabp. Facility medwatch (b)(4) received 02jan2019. Refer to mfg report # 2248146-2019-00045 for related iabc report.
 
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Brand NameUNKNOWN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key8278170
MDR Text Key134135724
Report Number2249723-2019-00127
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 other
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
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? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received08/05/2019
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: 01/25/2019 Patient Sequence Number: 1
Treatment
SENSATION PLUS 7.5FR. 40CC IAB
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