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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 Device Contamination with Body Fluid (2317); Unexpected Shutdown (4019)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 04/18/2021
Event Type  Injury  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp unit. Upon arrival at the customer's site, the fse attempted to turn on the iabp unit but it would not power on. The fse took pictures of all the boards and parts with visible blood contamination, and stated that for blood to enter and saturate the inside of iabp unit, blood would be visible through the iab tubing prior to entering the patient interface module and then the inside of the iabp console. As blood would start to enter the iabp unit through iab tubing, autofill alarms would be present. Per email from the customer, the end user ran the iabp until a system failure shutdown was present, caused by continued use of the iabp in which blood contamination spilled onto multiple internal boards. The iabp user manual describes the action that should have been taken by the operator. The fse concluded the reported event was caused due to user error. At this time, the customer has not requested for the iabp unit to be repaired as the fse has deemed the iabp unit a total loss. The iabp unit remains out of use pending a decision. A supplemental report will be submitted if additional information is provided.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump started alarming. The staff went into the patient's room to check the iabp unit and observed blood throughout the intra-aortic balloon (iab) tubing. A minute later, the iabp unit alarmed system failure and then turned off. The doctor was informed and cardiology was paged. The cardiology doctor attempted to pull out the iab, but the patient's blood pressure was observed to be a little high (sbp 160-170's). The patient was administered two doses of hydralazine. The doctor discontinued use of the iabp unit.
 
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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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11825146
MDR Text Key251189483
Report Number2249723-2021-01008
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/14/2021 Patient Sequence Number: 1
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