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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-CA
Device Problems Circuit Failure (1089); Disconnection (1171); False Reading From Device Non-Compliance (1228); Pressure Problem (3012)
Patient Problem No Information (3190)
Event Date 05/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Maquet (b)(4) requested the product back for investigation but it has not been received. Investigation is still pending. A supplemental medwatch will be submitted as soon as further information becomes available.
 
Event Description
Description from the customer report: "after 3 days of treatment, perfusion noticed that the venous pressure was reading +5mmhg. They used external pressure transducer to compare the internal and arterial readings and found a 20 mmhg discrepancy. They have no way of confirming the venous pressure since there are no luers on the venous side of the hls circuit but assume that since the venous pressure is reading positive values, it mist also be erroneous. They are monitoring the system closely. The circuit was discontinued as they weaned the patient. " (b)(4).
 
Manufacturer Narrative
An hls advanced 7. 0 module was returned to the factory in (b)(4) for investigation. During flushing of the oxygenator, no clots were visible. After cleaning, a crack on the luer lock of the blood outlet connector was found. The responsible quality engineer was informed, and the crack was glued to seal it, and the module was sent to the qa-laboratory for performance testing. The results of the performance testing from the qa-laboratory showed that while the gas exchange performance tests were passed by the product, it failed the pressure drop performance test. The product was returned to the decontamination / complaints laboratory where all four sides of the oxygenator were sawn open and the mats were inspected for damage, marks, or other anomalies. On the gas side, small clots could be seen between the mats. On the water side, larger/more clots could be seen between the gas and the water mats. No clots were visible on the blood distribution plate on the blood outlet side. The count of the gas mats (74) was within specification (a count 72, 74, or 76 is specified). The investigation concluded the most probable root cause for the increased pressure drop was blockage of the oxygenator as a result of clotting. As clotting can result from a number of causes, including patient condition, the anticoagulation measures in use, and other clinical factors, the exact reason for the clotting cannot be identified. A systemic issue is not indicated. No further investigation or action is currently warranted.
 
Event Description
(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 Key5723203
MDR Text Key48420899
Report Number8010762-2016-00383
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K101153
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,Followup
Report Date 05/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2017
Device Model NumberBEQ-HLS 7050-CA
Device Catalogue Number70106.4847
Device Lot Number70108810
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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