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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 8 PH.I.S.I.O.
Device Problems Low Readings (2460); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2017
Event Type  malfunction  
Manufacturer Narrative
Sorin (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell reservoir. The incident occurred in (b)(6). Per exemption number e2016005, (b)(4). The involved device was returned to sorin group italia for investigation. During visual inspection, no visible defects were noted. A gas exchange performance test was conducted per iso 7199 standard blood conditions. No device malfunction was identified during this testing. The involved device was found to be conforming to the manufacturer specifications. As the issue could not be reproduced, a root cause was not determined. However, the root cause is likely associated with the clinical practice.
 
Manufacturer Narrative
Patient information was not provided. The age of the device was calculated as the time elapsed between device sterilization and the date of the event. (b)(4). (b)(4) manufactures the inspire 8 hollow fiber oxygenator with integrated hardshell reservoir. The incident occurred in (b)(6). (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved device has been requested for return to sorin group (b)(4) for investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Sorin group (b)(4) received a report that low oxygen levels were found by the perfusionist for the inspire 8 hollow fiber oxygenator then the blood gas parameter was analyzed upon the start of bypass. The perfusionist decided to switch to a new membrane oxygenator to continue. The change out was done after cooling down of the patient. Oxygen levels were restored after the change out. There was no report of patient injury.
 
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Brand NameINSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA
strada statale 12 nord, 86
mirandola 41037
IT 41037
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola 41037
IT 41037
Manufacturer Contact
joan caesar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key6787410
MDR Text Key252914348
Report Number9680841-2017-00022
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2020
Device Model Number8 PH.I.S.I.O.
Device Catalogue Number050714
Device Lot Number1702060154
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/14/2017
Device Age5 MO
Event Location No Information
Date Manufacturer Received09/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2017
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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