MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-20 for BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG 00397 manufactured by Sorin Group Italia Srl.
[129315387]
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.
Patient Sequence No: 1, Text Type: N, H10
[129315388]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680841-2018-00031 |
| MDR Report Key | 8088344 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-20 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-10-26 |
| Date Facility Aware | 2018-10-26 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2018-05-07 |
| Date Added to Maude | 2018-11-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 7260 ENRICO MILANI |
| 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 SRL |
| Manufacturer Street | STRADA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA, MODENA 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| 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 | 2018-11-20 |
| Returned To Mfg | 2018-11-06 |
| Model Number | 00397 |
| Lot Number | 1802200146 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA SRL |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA, MODENA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |