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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 BEQ-HMOD70000-USA
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
The product was investigated in the laboratory of the manufacturer. During a tightness test a slight leakage at the dialysis lock and valve could be confirmed after one hour duration. Thus the reported failure could be confirmed. Dhr review result: affected product: basic lot 70118251 and packaging lot 70118230 (serial number ape (b)(4)). The avz from (b)(4) was reviewed on (b)(6) 2018. There were no references found, which are indicating a nonconformance of the product in question. 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).
 
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. The device was requested but not yet received.
 
Event Description
According to the customer: the customer reported the following in regards to blood leakage from the diacon connector: this was placed on a patient on (b)(6) at approximately 0930. From my understanding the small leak occurred right away, and again from the arterial side access port centered in the oxygenator. It has since clotted. (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 Key7171712
MDR Text Key264950582
Report Number8010762-2018-00004
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/04/2019
Device Model NumberBEQ-HMOD70000-USA
Device Catalogue Number701053824
Device Lot Number70118230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/01/2017
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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