MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-28 for BMR 1900 PH.I.S.I.O VENOUS RESERVOIR BAG 00398 manufactured by Sorin Group Italia.
[6192772]
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.
Patient Sequence No: 1, Text Type: D, B5
[14234405]
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.
Patient Sequence No: 1, Text Type: N, H10
[69132641]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680841-2015-00283 |
| MDR Report Key | 4963852 |
| Report Source | 05 |
| Date Received | 2015-07-28 |
| Date of Report | 2015-07-03 |
| Date of Event | 2015-07-03 |
| Date Mfgr Received | 2015-08-19 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-08-06 |
| 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 | CHERI VOORHEES, MGR., Q.A. |
| Manufacturer Street | 14401 W.65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676527 |
| Manufacturer G1 | SORIN GROUP ITALIA |
| Manufacturer Street | VIA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA(MO) |
| Manufacturer Country | IT |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BMR 1900 PH.I.S.I.O VENOUS RESERVOIR BAG |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2015-07-28 |
| Model Number | NA |
| Catalog Number | 00398 |
| Lot Number | 1502060041 |
| ID Number | NA |
| Device Expiration Date | 2018-01-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA |
| Manufacturer Address | 86,VIA STATALE 12 NORD, MIRANDOLA(MO) IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-28 |