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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX25RW
Device Problem Incorrect Device Or Component Shipped (2962)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the actual device; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available. (b)(4). Results code: results pending completion of evaluation. Conclusion code: conclusion not yet available-evaluation in progress.
 
Event Description
The customer reported to terumo cardiovascular that they received a case labeled 3cx-fx25rwc, but the product inside is actually 3cx-rx25rw. The outer box and the product show that the incorrect item was shipped. There was no patient involvement as this occurred during out of box.
 
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 december 20, 2016. (b)(4). A sample was not returned to confirm the product within the individual boxes; however, photos were provided that showed the outer case being labeled fx, and the internal boxes being originally labeled fx, with cross-outs and re-labeling of rx. Upon investigating the complaint occurrence, it was found that medline had incorrectly sent rx product to the hospital. Once this issue was realized by the hospital, they repackaged the rx product into fx boxes already at the hospital, marked the boxes as rx, and sent them back to medline. This was then re-entered into their inventory as fx product, which they then sent back to the hospital for a later order, without inspecting the internal product. Medline does not open the outer packaging of product to inspect the internal packaging or product. Due to this, and the re-packaging into the incorrect box, it was not discovered that rx product was returned for the first event. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameCAPIOX RX25 OXYGENATOR WEST
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6189705
MDR Text Key62858116
Report Number1124841-2016-00433
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153213
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 02/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*RX25RW
Device Catalogue NumberN/A
Device Lot NumberN/A
Other Device ID Number(01)00699753450110
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 Received02/01/2017
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

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