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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Backflow (1064); Fluid Leak (1250); Off-Label Use (1494)
Patient Problems Weakness (2145); Loss of consciousness (2418)
Event Date 11/20/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) will be reviewed once the dhr file is made available. A supplemental report will be submitted when additional information is made available. The name of the initial reporter listed is (b)(6). The full event site name is (b)(6).
 
Event Description
It was reported that a blood back occurred while the cs300 intra-aortic balloon pump (iabp) was in use on a patient. Frank blood was noted in the gas line. The patient became unresponsive and then woke up complaining of weakness on their side. An embolectomy was performed and the patient was able to move all extremities. The customer replaced the iab with another sensation plus 50cc; axillary approach (off-label use). It was reported that the embolectomy was not attributed to the iabp. There was no reported malfunction of the iabp unit. The related iab complaint has been reported under mfg report# 2248146-2018-00709.
 
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. A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and replaced multiple parts that were contaminated with blood. The fse replaced single transducer block assembly, purge valve assembly, fill manifold assembly, luer connector, blood detect tubing, safety disk assembly and condensate removal module (crm). Full functional and safety checks were performed and passed to factory specifications. The iabp unit was returned to the customer for clinical service.
 
Event Description
It was reported that a blood back occurred while the cs300 intra-aortic balloon pump (iabp) was in use on a patient. Frank blood was noted in the gas line. The patient became unresponsive and then woke up complaining of weakness on their side. An embolectomy was performed and the patient was able to move all extremities. The customer replaced the iab with another sensation plus 50cc; axillary approach (off-label use). It was reported that the embolectomy was not attributed to the iabp. There was no reported malfunction of the iabp unit. The related iab complaint has been reported under mfg report# 2248146-2018-00709.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8171924
MDR Text Key130614857
Report Number2249723-2018-02164
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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