MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number IN00631

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The complained inspire 6 oxygenator (catalog number 03706, lot number 1602290132) is a non-sterile unit that was assembled into a convenience pack that is not distributed in the usa.The item, lot number and expiration date provided refer to the convenience pack.As the convenience pack is not distributed in the usa, the udi is not applicable.The inspire 6 oxygenator is similar to the oxygenator 050717, which is distributed in the usa, for which the device identifier is (b)(4).The complained inspire 6 oxygenator was assembled into a convenience pack that is not distributed in the usa, but it is similar to the inspire 6 oxygenator 050717, which is distributed in the usa (510(k) number: k121909).The date of manufacture provided refers to the manufacture date of the convenience pack into which the complained oxygenator was assembled.Sorin group (b)(4) manufactures the inspire 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).(b)(4).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.A follow-up report will be sent when the investigation has been completed.(b)(4).

Event Description

Sorin group (b)(4) received a report that the po2 levels of the inspire 6 oxygenator were detected to be very low while at 100% fio2 near the end of the procedure.The physician elected to use an artificial respirator and not change out the oxygenator.There was no report of patient injury.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the inspire 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir.The incident occurred in (b)(6).(b)(4).The complained oxygenator was returned to sorin group (b)(4) and subjected to simulated used testing.The oxygenator was tested both according to relevant iso standard and in a way that simulated the use condition.Both functional tests showed that the oxygenator performed as expected.Based on the investigation results, the event does not appear to be ascribable to a device malfunction.The most probable root cause of the event is multi-factorial including interaction with clinical procedure and patient.As no device malfunction could be identified and the frequency of this kind of event is very low (b)(4), no corrective action is necessary.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
• Type of Device: OXYGENATOR, 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 Key: 6151669
• MDR Text Key: 61723357
• Report Number: 9680841-2016-00518
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IN00631
• Device Lot Number: 1603290046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/11/2016
• Device Age: 7 MO
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1