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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Problem Gradient Increase (1270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2021
Event Type  malfunction  
Manufacturer Narrative
The product and patient data were requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The following was reported by the customer: "customer had a patient on cardiohelp vv ecls. Over the course of 24 hours from 3/6/21 to 3/7/21, the delta p went from mid 20¿s to 140 and the pre pressure increasing as well over that time period. Please see attachment. The columns are recorded in 8 hour intervals and during that period please note the venous values which are ¿ values as they should be and then below are pre, post and delta p. You can also see on 3/7/21 at 1800 the circuit was changed and the pressures normalized. But before the circuit change, all values and increasing work was indicative of a clot on the pre membrane side. Flow was stopped, isolated the venous line and clamped off the patient and cut the venous line circuit and power flushed from the quick connect port on the oxygenator, the entire oxygenator and venous line. The entire circuit except for return line (red taped) line was rinsed with saline. No clots were in power flushed circuit nor in the venous line. We reconnect the venous line to the circuit and resumed therapy. Even with this power flush we were not able to identify any obstruction (clot) but to no avail the exact same pre pressure and delta p was on console. No harm was done to patient, just feel there could be an issue with the disposable. ".
 
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Brand NameHLS SET ADVANCED 7.0
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
kehler strasse 31
hechingen 76437
GM 76437
Manufacturer Contact
neue rottenburger strasse 37
kehler strasse 31
hechingen 76437
4972229321
MDR Report Key11526902
MDR Text Key246484233
Report Number8010762-2021-00199
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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