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

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.

• Brand Name: INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS RESERVOIR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 7137660
• MDR Text Key: 284349002
• Report Number: 9680841-2017-00034
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 10/03/2020
• Device Catalogue Number: 03707
• Device Lot Number: 1709120038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 01/30/2018
• Device Age: 3 MO
• Event Location: No Information
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

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