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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HMO 71000-J
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 09/03/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4) requested the product for investigation but the product was not available. The failure is already known to the manufacturer and has been thoroughly investigated under a previous complaint. The investigation results of this similar complaint are as follows: the product was investigated in the laboratory of the manufacturer. By visual inspection it was determined that within the dialysis lock and valve was blood. A tightness test was performed and a slight leakage was confirmed hereby. Thus the reported failure could be confirmed. The most probable cause of the reported failure is the detected offset which caused a leakage of the o-ring. Besides that mcp has decided, based on several complaints for the dialysis lock and valve showing the same symptoms with different material numbers than the one in this complaint, to initiate another capa (corrective and preventive action) in order to determine the root cause and initiate further actions to determine corrective measures for the failure as well as to clarify whether a systemic issue is present. All further steps will be performed in accordance to (b)(4). Additionally the data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations than the above mentioned will be completed at this time.
 
Event Description
(b)(4).
 
Manufacturer Narrative
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The device was requested but not yet received. A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
The customer used the hmo71000 for the surgery of the replacement of ascending thoracic aorta, and started cpb on at 8:41p. M. About 9:00 pm, the customer checked the oxygenator and found the blood was oozing from the dialysis lock valve. It was not much leakage, the customer continued to use the device and pcb off at 11:56 p. M. The surgery was finished with no impact from this incident. -no adverse effects on the patient. (b)(4).
 
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Brand NameOXYGENATOR, CARDIOPULMONARY BYPASS
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 Key6936511
MDR Text Key251874246
Report Number8010762-2017-00335
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K082117
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 11/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2019
Device Model NumberHMO 71000-J
Device Catalogue Number701048762
Device Lot Number70115449
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 Received11/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2017
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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