MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-04 for ORTHOPAT 2555-115-06 * manufactured by Haemonetics Corp.
[17172614]
Orthopat began bubbling in tubing back to reservoir. Changed machines and blood started spilling out of tubing. Blood contaminated. Approx 600cc lost from reservoir. New set up and new machine replaced and attached to drain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 386423 |
| MDR Report Key | 386423 |
| Date Received | 2002-04-04 |
| Date of Report | 2002-04-03 |
| Date of Event | 2002-03-05 |
| Date Facility Aware | 2002-03-05 |
| Report Date | 2002-04-03 |
| Date Reported to FDA | 2002-04-03 |
| Date Reported to Mfgr | 2002-04-03 |
| Date Added to Maude | 2002-04-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOPAT |
| Generic Name | AUTOTRANSFUSION SET |
| Product Code | CAO |
| Date Received | 2002-04-04 |
| Model Number | 2555-115-06 |
| Catalog Number | * |
| Lot Number | H01151 |
| ID Number | ZIMMER SALES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 375457 |
| Manufacturer | HAEMONETICS CORP |
| Manufacturer Address | 400 WOOD RD BRAINTREE MA 012849114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-04 |