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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX25RE
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 02/13/2020
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the device for evaluation; however, 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.(b)(4).
 
Event Description
The user facility reported to terumo cardiovascular, prior to cardiovascular bypass, during out of box,holes were noticed on the box upon received.Per user facility, a forklift hit the boxes during delivery.No patient involvement.
 
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 march 2, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 111, 4308) method code #1: 10 - testing of actual/suspected device method code #2: 3331 - analysis of production records results code: 111 - packaging problem identified conclusions code: 4308 - cause traced to transport/storage the sample was visually inspected and noted that there was a hole to the side of the outer boxes.The internal packaging was inspected and found the damage to the outer boxes caused holes in the inner boxes.Retention samples are not kept of the four pack shipping container.All capiox units are 100% visually inspected during and after packaging.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand Name
CAPIOX RX25 OXYGENATOR EAST
Type of Device
BLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key9777020
MDR Text Key200825105
Report Number1124841-2020-00052
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450103
UDI-Public(01)00699753450103
Combination Product (y/n)N
PMA/PMN Number
K153213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/15/2020
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 Other
Device Expiration Date10/31/2022
Device Model Number3CX*RX25RE
Device Catalogue NumberN/A
Device Lot NumberXN18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/14/2020
Initial Date FDA Received03/02/2020
Supplement Dates Manufacturer Received04/09/2020
Supplement Dates FDA Received04/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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