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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 HLM TUBING SET W/BIOLINE COATING
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The product was investigated at the lab of the manufacturer. A tightness test was performed on the blood side and at the water side of the product. Hereby no leakage could be confirmed, the product was tight. No abnormalities were detected during inspection of the product. Thus the reported failure could not be confirmed. The most probable cause of the reported incident is unknown. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.
 
Event Description
(b)(4). Related to complaint # (b)(4). For second product which was replaced at the same patient for the same incident.
 
Manufacturer Narrative
(b)(4). The device has been requested but not yet received. A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
During patient treatment air was detected in upper third of membrane. The oxygenator was replaced due to this. The air was detected by the bubble alarm of the cardiohelp device. The product was de-aired by the assistant medical director. (b)(4). For second product which was replaced at the same patient for the same incident.
 
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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 Key6697225
MDR Text Key250364452
Report Number8010762-2017-00208
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K080592
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 09/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2019
Device Model NumberHLM TUBING SET W/BIOLINE COATING
Device Catalogue Number701048127
Device Lot Number70117821
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
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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