MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-20 for GPS III MINI KIT W/30ML ACDA N/A 800-0505A manufactured by Biomet Orthopedics.
[20000334]
It was reported that patient underwent an elbow procedure on (b)(6), 2012. During the procedure, as the surgeon was extracting platelet poor plasma, platelet rich plasma leaked into the platelet poor plasma chamber. The procedure was completed using another kit, but only after a delay of more than half an hour occurred.
Patient Sequence No: 1, Text Type: D, B5
[20206380]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Review of returned device found that the buoy position and the number of red blood cells below the buoy were acceptable. Due to the dried blood and plasma, it was not possible to disassemble and evaluate the components dimensionally. Evaluation results were inconclusive.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00857 |
| MDR Report Key | 2623255 |
| Report Source | 07 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-05-17 |
| Date Mfgr Received | 2012-05-22 |
| Device Manufacturer Date | 2010-06-04 |
| Date Added to Maude | 2012-06-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GPS III MINI KIT W/30ML ACDA |
| Generic Name | SUPPLIES, BLOOD BANK |
| Product Code | KSS |
| Date Received | 2012-06-20 |
| Returned To Mfg | 2012-06-05 |
| Model Number | N/A |
| Catalog Number | 800-0505A |
| Lot Number | 002126 |
| ID Number | N/A |
| Device Expiration Date | 2013-07-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-20 |