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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 0998-00-0800-53
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem Vascular Dissection (3160)
Event Date 01/21/2017
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted. A company service representative was dispatched to evaluate the unit and was unable to reproduce any malfunction. The representative found no evidence of blood contamination in the unit or any other problems. The representative performed all functional, calibration and electrical safety tests per factory specifications, and unit was returned to customer for clinical use.
 
Event Description
On 1/20/2017, the customer initially reported that during use on a patient, blood was noted in the maquet balloon catheter. Subsequently, the patient was transferred to another facility, the balloon replaced and the patient placed on another pump. The customer then asked that the device be checked out to ensure that no malfunction of the pump had occurred. No adverse event was reported to us at this time. On 2/15/2017, we received medwatch #mw5067576 in which the customer reported that the patient sustained a serious injury on (b)(6) 2017 as a result of this event. Consequently, we contacted the customer to obtain information on this serious injury claim and on 2/17/2017, the customer reported the following additional information: the patient underwent left heart catheter complicated by dissection to mid-lad. Stent placement followed and balloon pump was placed for support and dopamine was started. Patient went to ccu with iabp 1:1, dopamine, propofol and intubated. Overnight lost augmentation and blood was noted in the iabp tubing. Furthermore, an additional report is being submitted with the information regarding the intra-aortic balloon (under (b)(4)).
 
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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 Key6353297
MDR Text Key68154840
Report Number2249723-2017-00007
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 02/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Other Device ID NumberCH226768A6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/24/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/08/2016
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: 02/23/2017 Patient Sequence Number: 1
Treatment
LINEAR 7.5 FR. 40CC IAB
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