MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-28 for D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER N/A 03387 manufactured by Sorin Group Italia.
[35036376]
At the date of the present report, the unit has not been returned to the manufacturer facilities for investigation. The arterial filter item (b)(4) was assembled into a customized circuit that is not distributed in the usa, but the complained device is similar to the arterial filter d733, which is distributed in the usa (510k#: (b)(4)). Sorin group (b)(4) manufactures the d733 micro 40 ph. I. S. O. Arterial filter. The incident occurred in (b)(6). This medwatch report is filled on behalf of sorin group (b)(4). Sorin group received a report that the a leak was found at the output port of the d733 arterial filter during priming. As the device was changed out, the blood output connector completely detached. 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
[35036377]
Sorin group received a report that the a leak was found at the output port of the d733 arterial filter during priming. As the device was changed out, the blood output connector completely detached. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[43720889]
Sorin group (b)(4) manufactures the d733 micro 40 ph. I. S. O. Arterial filter. The incident occurred in (b)(6). This medwatch report is filled on behalf of sorin group (b)(4). Sorin group received a report that the a leak was found at the output port of the d733 arterial filter during priming. As the device was changed out, the blood output connector completely detached. There was no patient involvement. The complained unit was returned to sorin group (b)(4) for evaluation. Visual inspection of the returned filter revealed that the blood outlet port was broken off at the base of the port, though no significant whitening or deformation was observed in the material at the break site. Closer inspection revealed that the tubing was inserted to the end of the port instead of being inserted 2-3mm away from the base as stated in the assembly procedure. This misassembly can result in the release of residual mold-in stress that can cause the port to break. The frequency of occurrence for this event is very low (<0. 001%). The manufacturing floor has been made aware of this issue. To prevent recurrence, a new training procedure was implemented to periodically sensitize and retrain personnel regarding complaints that are attributable to assembly errors on the manufacturing floor. Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680841-2015-00632 |
| MDR Report Key | 5330989 |
| Date Received | 2015-12-28 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2016-03-31 |
| Device Manufacturer Date | 2015-08-27 |
| Date Added to Maude | 2015-12-28 |
| 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 | CARRIE WOOD |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676461 |
| Manufacturer G1 | SORIN GROUP ITALIA |
| Manufacturer Street | VIA STATALE 12 NORD, 86 |
| Manufacturer City | MIRANDOLA, 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D733 MICRO 40 PH.I.S.O. ARTERIAL FILTER |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | JOD |
| Date Received | 2015-12-28 |
| Returned To Mfg | 2016-01-27 |
| Model Number | N/A |
| Catalog Number | 03387 |
| Lot Number | 1508270013 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA |
| Manufacturer Address | STRADA STATALE 12 NORD, 86 MIRANDOLA, 41037 IT 41037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-28 |