• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX OXYGENATOR 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
 

TERUMO CORPORATION, ASHITAKA CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*RX15RW40
Device Problem Break (1069)
Patient Problem Blood Loss (2597)
Event Date 02/11/2019
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown lot number. The actual device was not returned for evaluation, however, two photographs of the actual sample was provided. Therefore, the investigation was based upon the user facility information and the photographs provided by the user facility. Visual inspection of the photograph revealed the presence of blood adhering to the blood outlet port near the blood cardioplegia port. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record. Ifu states: do not use an oxygenator and reservoir that leaks. Replace it with another capiox rx15 oxygenator and reservoir. Recirculate the priming solution at a rate of 4l/min or higher to facilitate air removal. Failure to remove air from the oxygenator may result in serious injury to the patient. Band all connections in the circuit. Ensure that all connected parts including the luer caps, the lock adapters and the port caps are securely affixed. Loose connections may cause contamination or a blood leak. There is no evidence that this event was related to a device defect or malfunction. Based on the investigation results, it is likely that the red cap had not been attached to the blood cardioplegia port firmly, and/or the tube had not jointed to the blood cardioplegia port firmly, where blood leaked; or the tube had not been jointed to the blood outlet port firmly, where blood leaked. However, with no return of the actual sample to evaluate, the exact cause for the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported that the involved capiox rx was broken below the oxygenator, and then caused blood dripping. The amount of blood was reported to be unknown. The actual sample may have been changed out. The procedure outcome and patient impact was reported to be unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAPIOX RX OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
mark vornheder
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key8390343
MDR Text Key137822101
Report Number9681834-2019-00028
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K051997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*RX15RW40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/05/2019 Patient Sequence Number: 1
Treatment
BLOOD LINE CSS
-
-