MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number 00397

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

The bmr 1900 phisio closed venous reservoir bag is a non-sterile device assembled into a sterile convenience pack (item in00573, lot 1805070154) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the bag was assembled.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 bmr 1900l phisio bag is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone bag (catalog number 969000023) is registered in the usa (510(k) number: k112771).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the bag was assembled.Sorin group (b)(4) manufactures the bmr 1900 phisio closed venous reservoir bag.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).If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) has received a report that during priming, the venous in-let connector got disconnected from the bmr1900 bag.The issue occurred before use, during priming.There is no report of any patient injury.

Manufacturer Narrative

Sorin group italia manufactures the bmr 1900 phisio closed venous reservoir bag.The incident occurred in amsterdam-zuidoost, netherlands.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved bag was returned to sorin group italia with the connector completely detached.The tube was reconnected without additional bonding and a leak test was performed by filling the bag, mounting it on the dedicated bracket and pressurizing the bag to 0.1 bar for 15 minutes.The leak test confirmed a leak between the tube and the connector of the inlet line.No disconnection was observed.A review of the dhr did not reveal any relevant information possibly linked with the claimed defect.Investigation suggested that the root causes of the reported leak were a small deformation of the tube and a non-homogeneous distribution of solvent at the leaking point.Although the frequency of this type of event is very low and the risk associated is low, sorin group italia adjusted the tool used to enlarge the tube during the insertion of the connector to prevent possible tubing deformation during manufacturing.In addition, sorin group italia has begun performing in-process peel testing before batch release.Corrective actions have also been initiated to evaluate implementation of additional mitigation.

• Brand Name: BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena
• MDR Report Key: 8088344
• MDR Text Key: 129315387
• Report Number: 9680841-2018-00031
• Device Sequence Number: 1
• Product Code: DTN
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2021
• Device Model Number: 00397
• Device Lot Number: 1802200146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2018
• Device Age: 6 MO
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1