MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-27 for BMR1900 PH, I. S. I. O. VENOUS RESERVOIR BAG 00398 manufactured by Sorin Group Italia.
[25496905]
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.
Patient Sequence No: 1, Text Type: N, H10
[25496906]
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.
Patient Sequence No: 1, Text Type: D, B5
[69139635]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680841-2015-00318 |
| MDR Report Key | 5048904 |
| Date Received | 2015-08-27 |
| Date of Report | 2017-02-28 |
| Date of Event | 2015-07-28 |
| Date Facility Aware | 2015-08-10 |
| Date Mfgr Received | 2015-09-22 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-09-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOAN CEASAR |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| Manufacturer G1 | SORIN GROUP ITALIA |
| Manufacturer Street | STRADA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA (MODENA), 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BMR1900 PH, I. S. I. O. VENOUS RESERVOIR BAG |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2015-08-27 |
| Model Number | NA |
| Catalog Number | 00398 |
| Lot Number | 1504160088 |
| ID Number | NA |
| Device Expiration Date | 2016-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA |
| Manufacturer Address | VIA STATALE 12 NORD, 86 MIRANDOLA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-27 |