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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR HOLLOW FIBER MEMBRANE OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR

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SORIN GROUP ITALIA S.R.L. D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR HOLLOW FIBER MEMBRANE OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR Back to Search Results
Catalog Number 050531
Device Problems Low Readings (2460); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2017
Event Type  malfunction  
Manufacturer Narrative
Patient identifier was not provided. Initial reporter telephone number: (b)(6). The age of the device was calculated as the time elapsed between the device sterilization and the date of event. (b)(4). Sorin group (b)(4) manufactures the d 100 ph. I. S. I. O. Hollow fiber oxygenator. The incident occurred in (b)(6). Per exemption number (b)(4) , sorin group (b)(4) is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4). (importer). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not available for inspection.
 
Event Description
Sorin group (b)(4) received a report that the arterial gas (oxygen) levels of the d 100 ph. I. S. I. O. Oxygenator dropped to low values during a procedure. The procedure was completed without changing the oxygenator. There is no report of patient injury.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the d 100 ph. I. S. I. O. Hollow fiber oxygenator. The incident occurred in (b)(6). (b)(4). The device was not made available for investigation by the customer. However, the blood flow and oxygen flow data recorded by the customer during the procedure were provided, which indicated that the optimal gas/blood flow ratio described in the instructions for use (ifu) was not achieved, while maximum blood flow rate was exceeded. This may be the cause of oxygenator poor gas exchange. Without the ability to investigate the device, a device failure could not be confirmed and a root cause could not be determined. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
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Brand NameD 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
Type of DeviceHOLLOW FIBER MEMBRANE OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola (mo)
Manufacturer (Section G)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola (mo) 41037
IT 41037
Manufacturer Contact
joan ceasar
14401 w 65th way
arvada, CO 80004
2812287260
MDR Report Key6402817
MDR Text Key69951218
Report Number9680841-2017-00007
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/15/2019
Device Catalogue Number050531
Device Lot Number1603140132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/13/2017
Device Age11 MO
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2016
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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