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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION PRESCRIPTIVE OXY PACK - CAPIOX BLOOD GAS OXYGENATOR Back to Search Results
Model Number 74282
Device Problem Disconnection (1171)
Patient Problems Injury (2348); Blood Loss (2597)
Event Date 11/01/2019
Event Type  Injury  
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 of prescriptive oxygenator pack became disconnected. There was a 30 second delay. The product was not changed out. There was about 300 - 500 ml blood loss. The procedure was completed successfully.
 
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Brand NamePRESCRIPTIVE OXY PACK - CAPIOX
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer (Section G)
SAME
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key9364292
MDR Text Key167647819
Report Number1124841-2019-00314
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number74282
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/23/2019
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: 11/22/2019 Patient Sequence Number: 1
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