MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR; HOLLOW FIBER OXYGENATOR/RESERVOIR, MEMBRANE OXYGENATOR

Model Number D902

Device Problems Fluid/Blood Leak (1250); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was not provided.Patient sex was not provided.Patient weight was not provided.The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).(b)(4) manufactures the d902 dideco lilliput 2 infant hollow fiber oxygenator.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.No other similar complaints have been recorded on this device in the past three years.The involved device is not available 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.Device not available to be returned.

Event Description

Sorin group (b)(4) received a report that a blood to water leakage occurred in a lilliput 2 infant hollow fiber oxygenator during a procedure.A new oxygenator could not be primed due to the unavailability of blood so the patient temperature was recovered using a heater cooler and blanket.This reportedly took 2 hours.There was no report of patient injury.

• Brand Name: LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
• Type of Device: HOLLOW FIBER OXYGENATOR/RESERVOIR, MEMBRANE OXYGENATOR
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; strada statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: joan caesar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6816109
• MDR Text Key: 83627786
• Report Number: 9680841-2017-00023
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08033178100304
• UDI-Public: (01)08033178100304(17)190210(10)1602100009
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971877
• 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
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2019
• Device Model Number: D902
• Device Catalogue Number: 05324
• Device Lot Number: 1602100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/20/2017
• Device Age: 17 MO
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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
• Patient Age: 5 YR