MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-01 for UNIV OF VA CHARLOTTESVILLE, VA 1 047000100 manufactured by Sorin Group Usa, Inc..
[5899065]
Sorin group received a report that the tubing fell out of the arterial filter purge line luer and sprayed blood on the clinician. The product has been used for 5 days prior to the incident. No pt injury was reported and no blood was given to the pt to compensate for the sprayed blood.
Patient Sequence No: 1, Text Type: D, B5
[13392351]
Sorin group received a report that the tubing fell out of the arterial filter purge line luer and sprayed blood on the clinician. The product had been used for 5 days prior to the incident. No pt injury was reported and no blood was given to the pt to compensate for the sprayed blood. The investigation is ongoing. A f/u report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[32364013]
Sorin group received a report that the tubing fell out of the arterial filter purge line luer and sprayed blood on the clinician. The product had been used for 5 days prior to the incident. No patient injury was reported and no blood was given to the patient to compensate for the sprayed blood. Both an unused arterial filter purge line and the male luer fitting under complaint were returned to sorin group usa for evaluation. The mated tubing from the involved unit was not returned. Inspection of the returned devices under ultra violet light found that there was less solvent present on the involved male luer than on the unused unit. The lot number of the involved pack was not provided. Without a lot number the specific individual(s) responsible for this part of the assembly could not be identified. Therefore, a manufacturing awareness was issued to notify all production employees about the issue and heighten awareness to proper bonding technique. Without the lot number, the device history record could not be identified for review and the lot number for the involved tubing could not be identified so no review of receiving records or retain parts could be performed. No trends related to this issue have been identified. The reported issue occurred after 5 days of continuous use so the connection lasted well past the rated six hours of continuous use for this product. The sorin heart/lung perfusion pack instructions for use indicate, "this heart/lung perfusion pack is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours. " and "it is not designed for long-term use (greater than six hours)". Based on the information summarized above, no further actions are deemed necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718850-2015-00170 |
| MDR Report Key | 4818938 |
| Report Source | 05 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-05-11 |
| Date of Event | 2015-05-08 |
| Date Mfgr Received | 2015-10-28 |
| Date Added to Maude | 2015-06-23 |
| 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 USA, INC. |
| Manufacturer Street | 14401 W 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80004 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIV OF VA CHARLOTTESVILLE, VA 1 |
| Generic Name | CUSTOM PERFUSION PACK |
| Product Code | PIN |
| Date Received | 2015-06-01 |
| Model Number | NA |
| Catalog Number | 047000100 |
| Lot Number | UNK |
| ID Number | NA |
| 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 USA, INC. |
| Manufacturer Address | 14401 WEST 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-01 |