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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 OXY. W/ INTEGRATED HARDSHELL VENOUS RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS

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SORIN GROUP ITALIA S.R.L. INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 03707
Device Problem Complete Blockage (1094)
Patient Problem Death (1802)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
Sorin group (b)(4) manufactures the inspire 8m hollow fiber oxygenator. The incident occurred in (b)(6). Per exemption number e2016005, (b)(4). Both oxygenator modules involved in the event were returned together with the whole circuit to sorin group (b)(4) for investigation. However, fiber hydrophilization and massive clot presence did not allow execution of any functional testing. Based on the information provided, the procedure was a redo valve replacement and the patient was affected by endocarditis and heparin induced thrombocytopenia (hit). Management of anti-coagulation in the presence of hit can be problematic and the application of heparin in this specific case may have contributed to the observed coagulation phenomenon. A preexisting medical condition and/or clinical practice is one potential cause of the reported coagulation. The cause of the patient death was not reported. As an investigation could not be performed, an exact root cause was not determined.
 
Manufacturer Narrative
Patient information was not provided. Date of patient death was not provided. The inspire 8m hollow fiber oxygenator is a non-sterile device assembled into a sterile convenience pack (lot 1710050096) that is not distributed in the usa. The expiration date refers to the sterile finished product into which the oxygenator was assembled. The customer reported two devices involved in the event. The reported lot number refers to the non-sterile oxygenator that was returned to sorin group (b)(4) for investigation. As the sterile convenience pack is not distributed in usa, the udi number is not applicable. The age of the device was calculated as the time elapsed between device sterilization and the date of event. (b)(4). The complained inspire 8m hollow fiber oxygenator is a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand alone oxygenator (catalog number 050701) is registered in the usa (510(k) number: k130433). 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 inspire 8m hollow fiber oxygenator. The incident occurred in (b)(6). (b)(4). Reportedly, the patient was affected by heparin-induced thrombocytopenia, leading investigators to believe a coagulation disorder was the cause of the event. Sorin group (b)(4) has requested additional information to exclude potential relation between the device and the patient death. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved device has been returned 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 clot formation was observed in the reservoir of an inspire 8 hollow fiber oxygenator during an aortic valve replacement procedure. The oxygenator was changed out and the patient was given an anticoagulant (heparin). However, clotting was also observed in the second oxygenator and the procedure was terminated. The patient was affected by heparin-induced thrombocytopenia and reportedly expired.
 
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Brand NameINSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS RESERVOIR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L.
strada statale 12 nord, 86
mirandola, modena 41037
IT 41037
MDR Report Key7137660
MDR Text Key284349002
Report Number9680841-2017-00034
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other Health Care Professional
Device Expiration Date10/03/2020
Device Catalogue Number03707
Device Lot Number1709120038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Was the Report Sent to FDA?
Distributor Facility Aware Date01/30/2018
Device Age3 MO
Event Location No Information
Date Manufacturer Received01/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
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