MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 050702J

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.The expiration date refers to the sterile finished product.The complained inspire 6f m oxygenator (catalog number 050702j, lot 1905130001) is not distributed in the usa, therefore the udi is not applicable.The oxygenator item 050702j is similar to the inspire 6f m oxygenator 050702, which is distributed in the usa, for which the device identifier is (b)(4).The product item 050702j is not distributed in the usa and it is similar to the inspire 6f m oxygenator 050702, which is distributed in the usa (510(k) number: k180448).The device manufacture date refers to manufacture date of the sterile, finished oxygenator.Sorin group (b)(4) manufactures the inspire 6f m hollow fiber oxygenator with integrated arterial filter.The incident occurred in (b)(6).The involved oxygenator has been requested for investigation and it has not yet been returned to sorin group italia facilities.The review of the dhr of the oxygenator lot confirmed that the device was released in compliance with manufacturer specifications.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) has received a report that, after the begin of the extracorporeal circulation, the pos-lock connector which connects to the cardioplegia port of the inspire 6f oxygenator suddenly detached by the one-way valve.The procedure was completed without replacing the oxygenator.According to information, approximately 500ml of patient blood were lost.Medical team elected to transfuse blood bank to patient.There is no report of any patient injury.

Manufacturer Narrative

H.10: the involved inspire 6f m oxygenator was returned to livanova facility for investigation.Visual inspection of claimed oxygenator found the cardioplegia port on oxygenator module was severed at the thread level, thus preventing any possible further usage.To investigate possible non-conformity related with occurred issue, a dimensional analysis of the external diameter of cardioplegia port and of external diameter of cardioplegia port base was performed.Investigation confirmed the measured external diameters were falling within specifications.Manufacturing records review did not identify any relevant information possibly related with claimed issue.No further similar complaints have been recorded in last 12 months for cardioplegia port breakage during procedure, thus revealing the present case shall be reasonably considered an isolated issue.Based on collected evidences, the claimed breakage was confirmed.Livanova investigation could not identify any root cause of the issue.As this appears an isolated case and the root cause was not identified, no corrective action will be undertaken.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 9610287
• MDR Text Key: 202720792
• Report Number: 9680841-2020-00004
• 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: 12/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: 050702J
• Device Lot Number: 1905130001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1