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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIACASSIST INC. TANDEMHEART PUMP; NON-ROLLER TYPE BLOOD PUMP
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CARDIACASSIST INC. TANDEMHEART PUMP; NON-ROLLER TYPE BLOOD PUMP Back to Search Results
Model Number 5120-0000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemolysis (1886); Liver Damage/Dysfunction (1954); Renal Failure (2041)
Event Date 04/25/2018
Event Type  Injury  
Event Description
It was reported that during support of the tandemheart system the patient had hemolysis, acute renal failure and a shock liver.The patient had elevated lactose dehydrogenase, secondary to the hemolysis.The adverse events were reported to resolve without sequelae within 2 days of the onset.It was reported that the adverse events were potentially related to the tandemheart system however the direct cause of the relationship was not indicated.Attempts are underway for more information, but no additional information has been received to date.
 
Event Description
The patient¿s age and gender were provided.No additional, relevant information has been received to date.
 
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Brand Name
TANDEMHEART PUMP
Type of Device
NON-ROLLER TYPE BLOOD PUMP
Manufacturer (Section D)
CARDIACASSIST INC.
620 alpha drive
pittsburgh PA 15238
MDR Report Key8724007
MDR Text Key148835298
Report Number2531527-2019-00039
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
PMA/PMN Number
K110493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5120-0000
Device Catalogue Number5120-0000
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
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