• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 08/09/2017
Event Type  malfunction  
Manufacturer Narrative
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device has been requested but not received.A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
According to the customer: "two hours after the extracorporal circulation started at the cabg surgery, pa02 decreased to 130mmhg.The customer operated to increase fi02 from 65% to 70%, so that p02 increased to 266mmhg in the end.Stayed on the same device and continued the procedure.1 hour later, pa02 decreased again to 119mmhg before weaning, and p02 did not go up any more even if fi02 was adjusted 100%.The customer continued to use the device and the surgery was finished without any problem".No adverse effects on the patient (b)(4).
 
Manufacturer Narrative
The product was visually inspected in the laboratory of the manufacturer.No clots were detected.The product was cleaned with sodium hypochlorite solution.No other abnormalities were detected.Affected product: basic lot 70113492 and packaging lot 70115550 (serial number (b)(4).The avz from geq 300 to geq 314 (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.Thus the reported failure could not be confirmed.Based on the results obtained during investigation at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6816973
MDR Text Key83745853
Report Number8010762-2017-00274
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 10/27/2017
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 Date01/01/2015
Device Model NumberHMO 71000 J
Device Catalogue Number701048762
Device Lot Number70115446
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2017
Initial Date FDA Received08/24/2017
Supplement Dates Manufacturer Received10/27/2017
Supplement Dates FDA Received10/27/2017
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
Patient Sequence Number1
-
-