MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-10-20 for GPS3 SINGLE KIT W/BLOOD DRAW N/A 800-0675A manufactured by Zimmer Biomet, Inc..
[89952614]
Zimmer biomet complaint: (b)(4). Report source (b)(6). This report is being submitted late as it has been identified in remediation. Complaint sample was evaluated and the reported event was confirmed. Based on the information provided, the device functioned as intended. The red blood cells were isolated below the buoy and the platelet poor plasma remained above the buoy. The hemolysis that caused the red coloration of the plasma happened before the blood was loaded into the gps device. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[89952615]
It was reported that during an unknown procedure utilizing the gps iii, the components of the patient's blood separated poorly during centrifugation. No additional information has been provided. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-09318 |
| MDR Report Key | 6965666 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-20 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2015-07-20 |
| Device Manufacturer Date | 2015-04-29 |
| Date Added to Maude | 2017-10-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| 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 | GPS3 SINGLE KIT W/BLOOD DRAW |
| Product Code | JQC |
| Date Received | 2017-10-20 |
| Returned To Mfg | 2015-11-18 |
| Model Number | N/A |
| Catalog Number | 800-0675A |
| Lot Number | 501226 |
| ID Number | N/A |
| Device Expiration Date | 2017-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |