• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HMO 71000 J
Device Problem Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 10/26/2017
Event Type  malfunction  
Manufacturer Narrative
The product was investigated at the laboratory of the manufacturer. A tightness test was performed. A slight leakage was confirmed hereby. No further abnormalities were detected. Thus the reported failure could be confirmed. Mcp decided to initiate a capa (corrective and preventive action) process in order to determine the root cause and initiate further steps. All further steps will be performed out of the capa (b)(4) process. Most probable root cause identified: the injection molding tool for component "filterlid" (70103. 0908) has a separation which is directly placed on the sealing groove. The edges of this separation show wear. The injection molding tool process for component "filterlid" (70103. 0908) is not validated. Corrective / preventive actions plan: displacement of the form separation within the injection molding tool "(b)(4)" out of the sealing groove of component "filterlid" (70103. 0908). Initial sample testing of new components, due date: 2018-04-30. Displacement of the form separation within the injection molding tool "(b)(4)" for both cavities out of the sealing groove of component "bloodoutletlid" (70103. 0905) initial sample testing of new components, due date: 2018-04-30.
 
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4). The product was requested to return for manufacturer's laboratory investigation and was not yet received by the manufacturer. The investigation is still pending. A supplemental medwatch will be submitted when further information becomes available.
 
Event Description
According to the customer: 1 hour. After the extracorporeal circulation started, blood leakage from the dialysis lock valve was noted. The customer taped the leakage point and continued the procedure. They stayed on the same device as it was a slight leakage and finished the surgery without no effects on the patient. The pressure during pumping was 250mmhg. -no adverse effects on the patient. -the incident occurred during the patient use. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7028620
MDR Text Key254106914
Report Number8010762-2017-00360
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K090689
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 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2019
Device Model NumberHMO 71000 J
Device Catalogue Number701048762
Device Lot Number70115445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-