MAUDE Adverse Event Report: SORIN GROUP ITALIA BMR 1900 PH.I.S.I.O VENOUS RESERVOIR BAG; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Catalog Number 00398

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 07/03/2015

Event Type  malfunction  

Event Description

Sorin group rec'd a report that a leak was noted at the outlet port connector of the venous reservoir bag during priming.As the clinician tried to exchange the connector, the connector broke off.As this occurred during priming, there was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the bmr venous reservoir bag.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that a leak was noted at the outlet port connector of the venous reservoir bag during priming.As the clinician tried to exchange the connector, the connector broke off.As this occurred during priming, there was o patient involvement.Displayed on the heater-cooler during set up.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4) manufactures the bmr venous reservoir bag.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group received a report that a leak was noted at the outlet port connector of the venous reservoir bag during priming.As the clinician tried to exchange the connector, the connector broke off.This is a known issue.The partial or complete detachment of the connector from the tubing was causing the leak.Manual pulling of the connector is necessary to mount the bag on the holder, so the pulling force variability during the setup of the bag can cause a failure of the bonding adhesion.A capa was implemented to better characterize the pull force necessary to maintain the bag on the holder and to determine the relative adhesion specifications.A new piece of equipment for a more uniform and reliable solvent dispensing process on the connector and tubing will be implemented.

• Brand Name: BMR 1900 PH.I.S.I.O VENOUS RESERVOIR BAG
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA ; 86,via statale 12 nord,; mirandola(mo) ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA ; via statale 12 nord, 86; mirandola(mo) ; IT
• Manufacturer Contact: cheri voorhees, mgr., q.a. ; 14401 w.65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4963852
• MDR Text Key: 6192772
• Report Number: 9680841-2015-00283
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• PMA/PMN Number: K112771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2018
• Device Catalogue Number: 00398
• Device Lot Number: 1502060041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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