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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 OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA S.R.L. D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03813
Device Problems Low Readings (2460); Device Operational Issue (2914)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 02/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The involved device was returned to sorin group italia for investigation. During visual inspection, no visible defects were noted. A gas transfer test was conducted according to the instructions for use (ifu) with blood samples from both the venous and the arterial site. The values of o2 transferred and the measured pressure drop were within the expected range. A slight decrease of the co2 transferred value was observed, however this is expected as the device has already been used with blood and has a deposition of biological substance on the fiber bundle. According to the test results and above mentioned evaluations, the involved device was considered to have been properly manufactured and released in compliance to the relevant technical specifications. Sorin group italia has concluded that the event is not related to a device malfunction.
 
Manufacturer Narrative
The d100 ph. I. S. I. O newborn hollow fiber oxygenator was a non-sterile component assembled into a sterile convenience pack that is not distributed in the usa. The expiration date refers to the sterile finished product into which the oxygenator was assembled. As the sterile finished product is not distributed in the usa, there is no unique identifier (udi) number. However, the involved device is similar to d100 ph. I. S. I. O newborn hollow fiber oxygenator catalog number 050531, which is distributed in the usa, for which the device identifier is (b)(4). The age of the device was calculated as the time elapsed from device sterilization and the date of event. (b)(4). The d100 ph. I. S. I. O newborn hollow fiber oxygenator was a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand alone oxygenator (catalog number 050531) is registered in the usa (510(k) number: k061031). The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled. Sorin group (b)(4) manufactures the d100 ph. I. S. I. O newborn 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). The customer has not clarified the actual patient health condition. Several attempts have been made to contact the customer for additional information about the event and the involved patient. However, no additional information has been provided. 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 oxygen was not supplied to the d 100 ph. I. S. I. O. Oxygenator for unknown reasons during a procedure, and the blood was not oxygenated sufficiently. The saturation dropped and did not rise back up. A life-threatening condition appeared and the patient was placed on artificial lung ventilation. The patient is now in intensive care in critical condition. The extent of the damage suffered is unknown and the doctors have implemented life-support measures.
 
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Brand NameD 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola (modena)
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 Key6438397
MDR Text Key251473522
Report Number9680841-2017-00010
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 health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/29/2019
Device Catalogue Number03813
Device Lot Number1611160125
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/28/2017
Device Age3 MO
Event Location No Information
Date Manufacturer Received07/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2016
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: 03/28/2017 Patient Sequence Number: 1
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