MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 03813

Device Problems Low Readings (2460); Device Operational Issue (2914)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The involved device was returned to sorin group italia for investigation. During visual inspection, no visible defects were noted. A gas transfer test was conducted according to the instructions for use (ifu) with blood samples from both the venous and the arterial site. The values of o2 transferred and the measured pressure drop were within the expected range. A slight decrease of the co2 transferred value was observed, however this is expected as the device has already been used with blood and has a deposition of biological substance on the fiber bundle. According to the test results and above mentioned evaluations, the involved device was considered to have been properly manufactured and released in compliance to the relevant technical specifications. Sorin group italia has concluded that the event is not related to a device malfunction.

Manufacturer Narrative

The d100 ph. I. S. I. O newborn hollow fiber oxygenator was a non-sterile component assembled into a sterile convenience pack that is not distributed in the usa. The expiration date refers to the sterile finished product into which the oxygenator was assembled. As the sterile finished product is not distributed in the usa, there is no unique identifier (udi) number. However, the involved device is similar to d100 ph. I. S. I. O newborn hollow fiber oxygenator catalog number 050531, which is distributed in the usa, for which the device identifier is (b)(4). The age of the device was calculated as the time elapsed from device sterilization and the date of event. (b)(4). The d100 ph. I. S. I. O newborn hollow fiber oxygenator was a non-sterile component assembled into a convenience pack that is not distributed in the usa. The stand alone oxygenator (catalog number 050531) is registered in the usa (510(k) number: k061031). 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 d100 ph. I. S. I. O newborn hollow fiber oxygenator. The incident occurred in (b)(6). Per exemption number (b)(4), sorin group (b)(4). Is submitting the report for both sorin group (b)(4) (manufacturer) and (b)(4). (importer). The customer has not clarified the actual patient health condition. Several attempts have been made to contact the customer for additional information about the event and the involved patient. However, no additional information has been provided. 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. 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 oxygen was not supplied to the d 100 ph. I. S. I. O. Oxygenator for unknown reasons during a procedure, and the blood was not oxygenated sufficiently. The saturation dropped and did not rise back up. A life-threatening condition appeared and the patient was placed on artificial lung ventilation. The patient is now in intensive care in critical condition. The extent of the damage suffered is unknown and the doctors have implemented life-support measures.

• Brand Name: D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
• 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 41037 ; IT 41037
• Manufacturer Contact: joan caesar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6438397
• MDR Text Key: 251473522
• Report Number: 9680841-2017-00010
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/29/2019
• Device Catalogue Number: 03813
• Device Lot Number: 1611160125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 02/28/2017
• Device Age: 3 MO
• Event Location: No Information
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/28/2017 Patient Sequence Number: 1