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

Catalog Number 00398

Device Problems Break (1069); Component(s), broken (1103)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2015

Event Type  Other  

Manufacturer Narrative

Sorin group (b)(4) manufactures the bmr1900 the incident occurred in (b)(6).This medwatch reports is filed on behalf of sorin group (b)(4).Sorin group received a report that the outlet connector of a bmr1900 broke off while removing it from the bracket during priming.There was no pt involvement.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the outlet connector of a bmr1900 broke of while removing it from the bracket during priming.There was no pt involvement.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) manufactures the bmr 1900.The incident occurred in (b)(6).(b)(4).The complained unit was returned to sorin group (b)(4) for further investigation.Visual inspection confirmed that the blood outlet connector was completely broken off.Simulated use testing suggested that the force to induce breakage is significantly higher than the normal force applied to set-up and tear-down the bag form the bracket.In order to improve the resistance of the connectors to mechanical stress, a capa was initiated and the length of the pvc tubing was increased by 4mm.This change permits a reduction of the pull force to be applied to the connectors during the set-up and tear-down of the bag without impacting the positioning of the bag onto the bracket.An additional capa was initiated to guarantee correct distribution of the solvent by introducing a semi-automatic equipment to avoid excessive distribution of the bonding agent.The involved unit was manufactured before implementation of the above corrective actions.

• Brand Name: BMR1900 PH, I. S. I. O. VENOUS RESERVOIR BAG
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA ; via statale 12 nord, 86; mirandola ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA; 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: 5048904
• MDR Text Key: 25496905
• Report Number: 9680841-2015-00318
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K112771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 00398
• Device Lot Number: 1504160088
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/10/2015
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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