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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 Problems Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the correct serial number for the unit was not provided.There was no reported malfunction of the iabp and it is possible that the observed blood had not yet made its way into the iabp to trigger the "blood back" alarm.Additional information has been requested, and a supplemental and/or final report will be submitted if further information is provided.
 
Event Description
It was reported that during cardiosave intra-aortic balloon (iabp) therapy, a mega 50cc intra aortic balloon catheter (iabc) was inserted during cardiac catheterisation pre cardiac surgery due to disease process and haemodynamically unstable.The patient underwent cardiac surgery with counter-pulsation therapy continuing post surgery.Approximately 48 hours post surgery, the staff noticed blood in the extender tubing.However, the staff was unable to ascertain if the iabp had appropriately alarmed prior to the blood in the extender tubing.On noticing blood in the extender tubing of the iabc, counter-pulsation therapy ceased and the iabc was removed.The patient was on aspirin and clopidogrel.No adverse event was reported.A separate report is being submitted on the involved iabc.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) evaluated the iabp unit and verified blood ingress to the pneumatic module assembly (pma) with no malfunction of the iabp.The pma has not yet been replaced as getinge is waiting for the customer to approve the repair.
 
Event Description
It was reported that during cardiosave intra-aortic balloon (iabp) therapy, a mega 50cc intra aortic balloon catheter (iabc) was inserted during cardiac catheterisation pre cardiac surgery due to disease process and haemodynamically unstable.The patient underwent cardiac surgery with counter-pulsation therapy continuing post surgery.Approximately 48 hours post surgery, the staff noticed blood in the extender tubing.However, the staff was unable to ascertain if the iabp had appropriately alarmed prior to the blood in the extender tubing.On noticing blood in the extender tubing of the iabc, counter-pulsation therapy ceased and the iabc was removed.The patient was on aspirin and clopidogrel.No adverse event was reported.A separate report on the involved iabc has been submitted under medwatch #2248146-2018-00474.
 
Manufacturer Narrative
After the customer approved the repair of the iabp unit, the getinge field service engineer (fse) replaced the pneumatic module assembly and performed all functional and safety checks, which passed per factory specifications.The iabp was returned to the customer and cleared for clinical use.Full name of event site: (b)(6).
 
Event Description
It was reported that during cardiosave intra-aortic balloon (iabp) therapy, a mega 50cc intra aortic balloon catheter (iabc) was inserted during cardiac catheterisation pre cardiac surgery due to disease process and haemodynamically unstable.The patient underwent cardiac surgery with counter-pulsation therapy continuing post surgery.Approximately 48 hours post surgery, the staff noticed blood in the extender tubing.However, the staff was unable to ascertain if the iabp had appropriately alarmed prior to the blood in the extender tubing.On noticing blood in the extender tubing of the iabc, counter-pulsation therapy ceased and the iabc was removed.The patient was on aspirin and clopidogrel.No adverse event was reported.A separate report on the involved iabc has been submitted under medwatch #2248146-2018-00474.
 
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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
MDR Report Key7748900
MDR Text Key116246797
Report Number2249723-2018-01325
Device Sequence Number0
Product Code DSP
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/28/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-31
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Device AgeYR
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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