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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-HMOD 70000
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2017
Event Type  malfunction  
Manufacturer Narrative
The product was investigated in the manufacturer laboratory with the following outcome: a quadrox-id adult was sent back. The sample was contaminated. A luer lock on the blood outlet side has broken off. The broken luer lock with connection was not included. Cleaned with sodium hypochlorite. No further damage or abnormalities were found. A broken luer lock on the blood outlet side can be confirmed. No further damage or abnormalities were found. The most probable root cause could be the oblique termination edge suggesting a strong lateral mechanical action on the connector. Thus the failure could be confirmed. Since the reported failure did not contribute to a death or serious injury no corrective action is needed. In addition at this time it cannot be concluded that this is a systemic error. No corrective action is needed. 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.
 
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4). The device was requested but not yet received. A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
According to the customer: the patient was being transported when the luer lock at the top of the arterial side broke off. The nurse clamped the line and put her finger over the hole. They were able to resume adequate flow. The patient was emergently switched to cardiohelp. The patient appears to be stable (as to her baseline pre-event). No harm to the patient was reported. (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 Key6921816
MDR Text Key248777167
Report Number8010762-2017-00324
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
Type of Report Initial,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2018
Device Model NumberBEQ-HMOD 70000
Device Catalogue Number701053824
Device Lot Number70110006
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2016
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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