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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Hemolysis (1886)
Event Date 08/04/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The hls module advanced 7. 0 in this case was returned to the factory and investigated in the decontamination / complaints laboratory. Blood clots were visible on flushing out the oxygenator with water. The sample had to be cleaned three times with sodium hypochlorite solution until all clots were removed. During the leakage test on the blood side according to lv201, no leaks were found. O for further examination, the product was forwarded to the qa laboratory. In the qa laboratory, hemolysis testing was performed for a period of 6 hours, and no anomalies were found. The product is working as specified. A product problem is not indicated. A questionnaire was sent to the ssu to obtain information from the customer to be able to carry out a clinical assessment of the case. No reply on clinical assessment questions could be obtained after four good faith effort (gfe) attempts, so there is insufficient information to clinically assess the reported issue. The probable root cause of the issue is considered to be clinical in nature, although it is not possible to establish the exact root cause, especially when taking into account the critical condition of the patient and the patient's pre-existing, severe medical conditions. Based on the investigation and trending for this issue, neither a systemic issue nor a manufacturing problem is indicated, therefore no further investigation or action is currently warranted, and the complaint will be closed.
 
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted if additional information becomes available. (b)(4).
 
Event Description
Description from the customer report: "a (b)(6) male going into cariogenic shock due to a acute onset of vsd secondary to infarc. Patient was placed on va ecls support via right femoral vein and left femoral artery with an iabp placed via right femoral artery. Patient anti coagulated with bilirubin with act¿s in the 170s to 180s. Within 24hrs, a higher hemolysis factor than normally seen was observed. Within 48hrs the hemolysis was severe enough that the patient was taken back to surgery to reconfigure the cannulation sites. While in surgery the vsd was repaired and arterial site was moved to axillary. A venous cannula was placed in the ra as well as a lv vent in addition to the existing cannula in the right femoral vein. Because the cause of hemolysis could not be identified, the cardiohelp disposables were also replaced in an effort to arrest the hemolysis problem. Within 24hrs of these changes it was noticed that the hemolysis was beginning to attenuate. " (b)(4).
 
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Brand NameHLM TUBING SET W/BIOLINE COATING
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 Key5890790
MDR Text Key112611638
Report Number8010762-2016-00531
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
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 08/08/2016,07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number701052794
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/19/2016
Device AgeYR
Event Location Hospital
Date Report to Manufacturer08/08/2016
Date Manufacturer Received08/08/2016
Was Device Evaluated by Manufacturer? Yes
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: 08/19/2016 Patient Sequence Number: 1
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