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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
Catalog Number 0998-00-3023-XX
Device Problems Decrease in Suction (1146); Occlusion Within Device (1423); Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Nausea (1970); Pain (1994)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed as the serial number of the iabp was not provided by the facility. At this time, the facility has not determined which iabp was in use during this event. Additional information has been requested, and we will report accordingly if it becomes available.
 
Event Description
It was reported that a cs300 iabp (intra-aortic balloon pump) with a maquet 7. 5fr 40cc iab was placed on a patient on (b)(6) 2017. On (b)(6) 2018 the iabp alarmed "low vacuum" and the patient was repositioned. The iabp then alarmed "check tubing" and blood was noted in tubing. The patient had abdominal pain and the iabp was placed on standby. The patient had urge to have bowel movement, was nauseated and diaphoretic. The iabp was then removed. Vascular surgery consult was done. A computed tomography (ct) of chest, abdomen and pelvis was negative for direction or aneurysm. The patient was planned for high risk percutaneous coronary intervention on 1/2 impella percutaneous lvad (left ventricular assist device) placement and ptca (percutaneous transluminal coronary angioplasty) and des (drug-eluting stent) and l (left)lm/lcx (left main/left circumflex artery) isr (in-stent restenosis) patient death occurred on (b)(6) 2018. The facility does not attribute the death to the device. A separate report was submitted for the related intra-aortic balloon under mfg report number: 2248146-2018-00046.
 
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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
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7311840
MDR Text Key101769858
Report Number2249723-2018-00338
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-3023-XX
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 Received02/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/02/2018 Patient Sequence Number: 1
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