MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for UNKNOWN GPS III PLATLET CONCENTRATION SYSTEM N/A UNKNOWN BIOLOGICS manufactured by Zimmer Biomet, Inc..
[89365612]
Customer has indicated that the product will not be returned to zimmer biomet. Reviewed with design engineer - from the photos, it is possible that the ppp and prp were all taken out of the same port at the same time and mixed back together again. However, without the opportunity to examine the complaint product, root cause cannot be determined. Part and lot identification are necessary for review of device history records and complaint history, neither were provided. 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
[89365613]
It was reported after the centrifugation of the blood it has been noticed that the blood was not properly separated. The surgeon used another blood sample to complete the infusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07860 |
| MDR Report Key | 6911528 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-10-12 |
| Date of Event | 2016-04-29 |
| Date Mfgr Received | 2017-10-12 |
| Date Added to Maude | 2017-10-03 |
| 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 | 0 |
| Brand Name | UNKNOWN GPS III PLATLET CONCENTRATION SYSTEM |
| Product Code | JQC |
| Date Received | 2017-10-03 |
| Model Number | N/A |
| Catalog Number | UNKNOWN BIOLOGICS |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-03 |