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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2016
Event Type  Injury  
Manufacturer Narrative
Maquet cardiopulmonary requested the product back for investigation but product was not available. Furthermore product data regarding the involved set has been requested but none could be provided by customer. Only the data of the involved oxygenator has been submitted to manufacturer. A review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found. Based on this a confirmation of the failure is not possible. Since the reported failure did not contribute to a death or serious injury no corrective action is needed. In addition at this time it cannot be concluded that this is an systematic error. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary. Due to this no further investigation initiations will be completed at this time. Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-i which is registered under 510(k): k082117.
 
Event Description
Description from the customer report: "as soon as we went on cardiopulmonary bypass the abg showed low po2 40mmhg even with 100% fi02 and blood flow of 4. 0l/min. Need to change oxygenator and resume bypass" (b)(4).
 
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Brand NameHLM TUBING SET
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key5752023
MDR Text Key48290186
Report Number8010762-2016-00411
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K082117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2016 Patient Sequence Number: 1
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