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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Renal Failure (2041); Test Result (2695)
Event Type  Death  
Manufacturer Narrative
Additional information has been requested from the customer, and will be reported if made available to us.
 
Event Description
The customer reported that the patient had a myocardial infarction (mi) and required intra-aortic balloon pump (iabp) therapy, which was inserted under fluoroscopy.This was reported to have been uneventful, and the patient was scheduled to be operated on when the patient's troponin levels dropped.As per hospital's ward protocol, the patient was put on a heparin infusion, and on the sixth (6th) postoperative day, it was reported that the patient had a retro-peritoneal bleed from the opposite groin to the iabp and was bleeding out.The heparin was stopped.The peritoneal bleed could have been evacuated, but was judged to be limited, and monitored instead.The patient subsequently went into renal failure, and died.The customer is questioning the use of heparin for the iabp patients and is specifically interested in the protocol for its use in iabp therapy, and is speculating if the use of heparin with the iabp may have caused /accelerated the problem.However, the customer is not attributing the patient's death or serious injury to the iabp.
 
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.However, the customer did confirm that it was a maquet/ getinge iabp.No additional information has been received from the customer after various attempts were made requesting relevant data.If any pertinent information is received in the future, a supplemental report will be provided appropriately.
 
Event Description
The customer reported that the patient had a myocardial infarction (mi) and required intra-aortic balloon pump (iabp) therapy, which was inserted under fluoroscopy.This was reported to have been uneventful, and the patient was scheduled to be operated on when the patient's troponin levels dropped.As per hospital's ward protocol, the patient was put on a heparin infusion, and on the sixth (6th) postoperative day, it was reported that the patient had a retro-peritoneal bleed from the opposite groin to the iabp and was bleeding out.The heparin was stopped.The peritoneal bleed could have been evacuated, but was judged to be limited, and monitored instead.The patient subsequently went into renal failure, and died.The customer is questioning the use of heparin for the iabp patients and is specifically interested in the protocol for its use in iabp therapy, and is speculating if the use of heparin with the iabp may have caused /accelerated the problem.However, the customer is not attributing the patient's death or serious injury to the iabp.
 
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Brand Name
UNKNOWN
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key6850920
MDR Text Key85270595
Report Number2249723-2017-00440
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 08/14/2017
Initial Date FDA Received09/07/2017
Supplement Dates Manufacturer Received11/13/2017
Supplement Dates FDA Received11/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
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