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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA S.R.L. INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 050710
Device Problems Disconnection (1171); Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2016
Event Type  No Answer Provided  
Manufacturer Narrative
The complained inspire 8 start oxygenator (catalog number 050710, lot 1511020143) is not distributed in the usa, therefore the udi is not applicable. The oxygenator item 050710 is similar to the inspire 8 oxygenator 050714, which is distributed in the usa, for which the device identifier is (b)(4). The product item 050710 is not distributed in the usa, but it is similar to the inspire 8 oxygenator 050714, which is distributed in the usa (510(k) number: k130433). Sorin group (b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Investigation is on-going. A follow-up report will be sent when the investigation is complete. Device not available for return.
 
Event Description
Sorin group (b)(4) received a report that the transmembrane pressure of the inspire 8 start hollow fiber oxygenator increased and the tubing disconnected from the arterial outlet of the oxygenator. The connection was replaced and the procedure was been continued at a lower blood flow rate. Near the end of the procedure, the user observed the po2 pressure to be very low (90-100mmhg), despite 100% fio2. According to the medical team, the blood loss was 200-400cc and blood had to be transfused to the patient. The conditions of the patient have been reported to be stable.
 
Manufacturer Narrative
(b)(4) manufactures the inspire 8 start hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir. The incident occurred in (b)(6). The involved oxygenator and the circuit into which the oxygenator was assembled were not made available for investigation at sorin group (b)(4). Therefore, a physical investigation of the unit could not be performed. The pump sheet for the case was provided. However, blood flow data was not included in the sheet. Without the ability to perform a physical investigation of the complained device, an exact root cause could not be determined and corrective actions were not identified. However, investigation of similar events and ongoing review of available medical literature suggests the most probable root cause of platelet adhesion and coagulation is multi-factorial and potentially is influenced by the clinical procedure (e. G surgical material), therapies used (e. G. Anticoagulant prescription, heparin composition and priming composition) and patient-specific health conditions. The oxygenator was manufactured, tested and released in compliance with standard manufacturing procedures. Sorin group (b)(4) will continue to monitor for trends related to this type of issue. Device not available.
 
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Brand NameINSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
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 (modena) 41037
IT 41037
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6186184
MDR Text Key62849728
Report Number9680841-2016-00520
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 11/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/02/2018
Device Catalogue Number050710
Device Lot Number1511020143
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2015
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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