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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS PRESCRIPTIVE OXY PACK - CAPIOX BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS PRESCRIPTIVE OXY PACK - CAPIOX BLOOD GAS OXYGENATOR Back to Search Results
Model Number 74283
Device Problem Disconnection (1171)
Patient Problems Injury (2348); Blood Loss (2597)
Event Date 11/01/2017
Event Type  Injury  
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 november 17, 2017. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
Manufacturer Narrative
The returned sample was visually inspected. Nothing was noted on the device other than dried blood from the reported disconnect. Sample was connected to a manometer and pressurized with water up to 500 mmhg (clinically relevant pressure) and inspected for any signs of leaks. The line was manually put under repeat tension and manipulated to determine if the line would disconnect. The unit did not disconnect. Based on the results, the most likely cause of the reported disconnect was due to either the line not being fully connected or something had depressed the lever for disconnecting the quick connect. 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. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the quick connect on the outlet of the oxygenator came apart. It was separated while warming on the circuit arrest case. There was zero activity at the field and zero change in flow or pressure. The patient was given 3 units of blood. There was a blood loss of 800 ml. There was a delay for 30-60 seconds. Product was not changed out. Procedure was completed successfully.
 
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Brand NamePRESCRIPTIVE OXY PACK - CAPIOX
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key7042257
MDR Text Key249629837
Report Number1124841-2017-00239
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,Followup
Report Date 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number74283
Device Catalogue NumberN/A
Device Lot NumberVK14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2017
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: 11/17/2017 Patient Sequence Number: 1
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