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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem Loss of consciousness (2418)
Event Date 08/03/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.Additional information has been requested from the customer.If the information is provided, it will be reported accordingly.
 
Event Description
It was reported that the nurse responded to a cardiosave intra-aortic balloon pump (iabp) alarm.The patient was asleep in the recliner.The nurse found the iabp on standby mode and noted blood in the catheter tubing.The physician was then notified as the staff assisted the patient back to bed.Initially, the patient was unresponsive so the team intubated and a stroke alert was called.The physician disconnected the iabp at the bed side.The patient was then taken for ct scan and an eeg was completed at the bed side.The patient remains on a ventilator and is able to open eyes and squeeze with left hand.However, the patient is unable to move bilateral lower extremities and right arm/right hand.This report is related to iab complaint reported under mfg report number 2248146-2018-00516.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.The fse disassembled the iabp unit and traced blood back up to the drive assembly.The fse then replaced the pim (pneumatic module assembly) with safety disk, drive assembly and pim to backplane cable assembly.The fse reassembled and performed a complete functional test.The iabp unit passed all tests and calibrations and was cleared for clinical use.
 
Event Description
It was reported that the nurse responded to a cardiosave intra-aortic balloon pump (iabp) alarm.The patient was asleep in the recliner.The nurse found the iabp on standby mode and noted blood in the catheter tubing.The physician was then notified as the staff assisted the patient back to bed.Initially, the patient was unresponsive so the team intubated and a stroke alert was called.The physician disconnected the iabp at the bed side.The patient was then taken for ct scan and an eeg was completed at the bed side.The patient remains on a ventilator and is able to open eyes and squeeze with left hand.However, the patient is unable to move bilateral lower extremities and right arm/right hand.This report is related to iab complaint reported under mfg report number 2248146-2018-00516.
 
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Brand Name
CARDIOSAVE
Type of Device
SYSTEM, 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 Key7826457
MDR Text Key118874054
Report Number2249723-2018-01487
Device Sequence Number1
Product Code DSP
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 company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device Age YR
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age61 YR
Patient Weight79
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