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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 Device Displays Incorrect Message (2591)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided. The customer has not requested getinge to evaluate the iabp in question. However, additional information has been requested, and a supplemental report will be submitted.
 
Event Description
It was reported that during in use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a "catheter restriction" alarm. There were no indications of a leak present and the connections were secure when checked. Patient's flat suggested the possibility of a kink in the catheter. There was no unusual movement prior to the iabp alarming, and the patient was not on a ventilator. While a getinge representative was troubleshooting, the cardiologist walked in, and the nurse asked the representative to call back as he was assessing the situation. The representative then received an urgent call stating that the patient was coding; therefore, a call back was delayed about 45 mins. Upon calling back, the doctor reported trying to reposition the catheter which did not help. He stated that the patient's hemodynamics were good and was going to have the support discontinued. The patient was scheduled to go to the operating room and went for surgery about 30 minutes later. There was no report of patient injury or adverse event post-operatively. The related intra-aortic balloon (iab) to this event was reported under mfg report number 2248146-2018-00354.
 
Manufacturer Narrative
On (b)(4) 2018, we confirmed that there was an error with transposition of information involving this and another complaint (mfg report number 2249723-2018-00999), which resulted in the patient coding being incorrectly captured and reported under this complaint. However, there was no adverse event involved in this complaint and there was no alleged malfunction of the iabp. Complaint investigation is only required on the iab catheter; consequently, this complaint has been deemed invalid and will be cancelled in our database.
 
Event Description
It was reported that during in use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a "catheter restriction" alarm. There were no indications of a leak present and the connections were secure when checked. Patient's flat suggested the possibility of a kink in the catheter. There was no unusual movement prior to the iabp alarming, and the patient was not on a ventilator. No adverse event was reported. The related intra-aortic balloon (iab) to this event was reported under mfg report number 2248146-2018-00354. On (b)(6) 2018, we confirmed that there was an error with transposition of information involving this and another complaint (mfg report number 2249723-2018-00999), which resulted in the patient coding being incorrectly captured and reported under this complaint. However, there was no adverse event involved in this complaint and there was no alleged malfunction of the iabp. Complaint investigation is only required on the iab catheter; consequently, this complaint has been deemed invalid and will be cancelled in our database.
 
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Brand NameCARDIOSAVE
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 Key7545189
MDR Text Key109306088
Report Number2249723-2018-00892
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
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received05/25/2018
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: 05/25/2018 Patient Sequence Number: 1
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