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Model Number HLS SET
Device Problem Failure to Deliver (2338)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that during patient treatment the po2 decreased to 56. The product was exchanged - the patient was moved from cardio help to centragmag and quadrox. The patient was stable. As the product in question is contaminated with the coronavirus sars-cov-2 it was not requested to be returned by the customer due to the high risk of spreading the virus. Therefore, no laboratory investigation could be performed by the manufacturer. A device history record review of the affected oxygenator was not possible as no serial number could be obtained from the customer. A device history record review of the oxygenator batch (lot 70138328) was performed with the following outcome: the dhr for the hls module advanced adult (material: 70105. 4378, lot: 70138328 dms#: (b)(4)) for which a customer complaint was received, was reviewed on 2020-10-15. The dhr does not show any abnormality or issue that is related or can have led to the customer complaint. The reported failure was already investigated in similar complaint # (b)(4) with the following results: results of laboratory investigation: during optical inspection heavy clotting was detected in the oxygenator. No leaks were noticed during the leak test carried out according to lv 201. No pressure abnormalities or leaks were detected during the functional test using the cardiohelp. The hls set worked according to its specifications. Furthermore a dhr review was performed in regard to similar complaint # (b)(4). No abnormality, or issue was found that is related, or can have led to the customer complaint. Based on the similar complaint, investigation the reported failure could be confirmed but was not be attributed to a device related malfunction. The most probable root cause of the reported event could be coagulation. Due to the impaired blood flow the oxygenation performance of the oxygenator was decreased. According to the ifu hls set advanced 5. 0 / 7. 0 1. 6 / g-670/ 02 chapter 4. 2 safety instructions for the extracorporeal circulation following causes could led to coagulation: no anticoagulation, or insufficient anticoagulation causes occlusion of the extracorporeal circulation, and the patient circuit. This can lead to inadequate patient support, hemolysis or thrombus formation in the patient. Weigh the benefits of extracorporeal circulation against the risk of systemic anticoagulation. Use anticoagulants; e. G. Heparin or argatroban. Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time). Ensure that the act value does not fall below the value which is appropriate for the application. Check the coagulation status of the patient's blood regularly. The protocol for coagulation management is the responsibility of the user in charge. When the event occurred, the device was being used for treatment of the patient. The product was directly involved in the event. The occurrence rate regarding the above complaint is below the acceptance rate. Thus, no remedial action required. The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations, or corrections will be implemented in case of adverse trending.
Event Description
The customer has 2 cardio helps, requested a 3rd rental, and none available. The patient is covid positive and pregnant. The times and gas levels below: (b)(6). All gases are post membrane oxygenator on (b)(6) 2020; complaint id: (b)(4).
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Manufacturer (Section D)
neue rottenburger strasse 37
Manufacturer (Section G)
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
MDR Report Key10703858
MDR Text Key214790243
Report Number8010762-2020-00349
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLS SET
Device Catalogue Number70105.2797
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 Received10/05/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial