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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SX OXYGENATOR W/HR (STERILE) BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SX OXYGENATOR W/HR (STERILE) BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CXSX18R
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Patient Involvement (2645)
Event Date 06/23/2017
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on july 21, 2017. The electronic shipment of the affected product code and lot number from the tennessee distribution center to terumo (b)(4) was tracked. Several shipments were made from the distribution center; however, the total number of units that were described to be ordered and received were not all from this lot. Upon investigating the shipment of the affected product, no issues were noted. The product was not found at the distribution center, and there had been multiple verifications of the shipments accuracy prior to the product leaving the dc. It is possible that there may have been an issue in the shipping after the product left the terumo facility, or there was a miscount of product once it was received; however, neither cause could be confirmed. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. For this reason, terumo references evaluation conclusion. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during out of box, 16 units were short shipped. *no patient involvement as this occurred during out of box.
 
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Brand NameSX OXYGENATOR W/HR (STERILE)
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6734279
MDR Text Key247166596
Report Number1124841-2017-00150
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2019
Device Model Number3CXSX18R
Device Catalogue NumberN/A
Device Lot NumberUE25
Other Device ID Number00699753450035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2016
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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