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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 Device Operates Differently Than Expected (2913)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/06/2017
Event Type  malfunction  
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 customer used hmo71000 for the surgery of the replacement of descending thoracic aorta the extracorporeal circulation was started.(after 6 hours) the customer observed that the po2 was low (105).The customer increased fio2 from 50% to 80%.Po2 exceeded 300.The customer observed the po2 was low (21).The customer increased fio2 to 100% and then, po2 exceeded 100.The customer increased the gas flow to10l.P02 did not go up more than 100.The extracorporeal circulation was finished.-no adverse effects on the patient -the product will be delivered to mcp (b)(4).
 
Manufacturer Narrative
(b)(4).The product was visually inspected in the laboratory of the manufacturer.On the blood inlet and outlet side no clots were detected.During rinsing no clots were flushed out.The product was cleaned with sodium hypochlorite solution.No other abnormalities were detected.For further examination all four sides of the oxygenator were sawn open, and the mats were inspected for any signs of damage, marks or any other anomalies.No abnormalities were found.The number of gas mats was also counted, and there are 74 mats on the gas side and 23 mats on the side of the heat-exchanger this is within specification.There were no signs of any clotting between the mats, or anything else of note.Thus the reported failure could not be confirmed.Dhr review:affected product: basic lot 70113490 and packaging lot 70113491 (serial number (b)(4)).The avz from ggx 600 to ggx 614 (b)(4) was reviewed on (b)(6) 2017.There were no references found, which are indicating a nonconformance of the product in question.Additionally a review of the weekly performance monitoring according to si-c-09 has been reviewed (b)(4), the performance tests passed the acceptance criteria.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.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).
 
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Brand Name
OXYGENATOR, CARDIOPULMONARY BYPASS
Type of Device
OXYGENATOR, 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 Key6672779
MDR Text Key78786235
Report Number8010762-2017-00205
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 09/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2018
Device Model NumberHMO 71000-J
Device Catalogue Number701048762
Device Lot Number70113491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2017
Initial Date FDA Received06/28/2017
Supplement Dates Manufacturer Received09/07/2017
Supplement Dates FDA Received09/21/2017
Date Device Manufactured11/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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