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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number VKMO 31000
Device Problems Leak/Splash (1354); Failure to Prime (1492)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it until yet. Investigation is pending. A supplemental medwatch will be submitted as soon as further information becomes available. Additional information: the product mentioned is a vkmo and the included affected component has the contributing design function of the quadrox-i pediatric which is registered under 510(k): k101153.
 
Event Description
(b)(4). Description from the customer report: "the customer experienced a leak from the hmo while priming. Leaking from ll ports on arterial outlet side of hmo. Leakage on luer lock on blood outlet connector. " (b)(4).
 
Manufacturer Narrative
Complaint was in additionally investigated by maquet cardiopulmonary (b)(4). The possible cause could be determined as a missing visual control before assembly and damaged parts during transportation. The design of the packaging has been reviewed by the construction team of maquet turkey. The investigation result of the packaging method of the set shows that the failure could not be caused during packing. Furthermore the dhr for the product does not have any abnormalities. As a corrective action, 100% control instruction has been implemented to visual control of the oxygenators before the assembly. Moreover, the visual control points of the oxygenator have been explained to the operators with the support document. Additionally the operators are informed about the complaint. Investigation still pending. A supplemental medwatch will be submitted as soon as further information becomes available.
 
Event Description
(b)(4).
 
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Brand NameHLM TUBING SET W/SOFTLINE 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 Key5480759
MDR Text Key39980504
Report Number8010762-2016-00138
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K132829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2016
Device Model NumberVKMO 31000
Device Catalogue Number70104.9185
Device Lot Number92135383
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
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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