MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-21 for GPS III MINI PLATELET CONCENTRATE SEPARATION KIT N/A 800-0505A manufactured by Zimmer Biomet, Inc..
[124476991]
Zimmer biomet complaint number - (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded
Patient Sequence No: 1, Text Type: N, H10
[124476992]
It was reported that during an office injection the blood was spun in the centrifuge and the blood did not separate. The surgeon believed that the buoy failed to spin and didn't separate. The procedure had to be stopped. Approximately a week later on an unknown date, the patient's blood was re-drawn and the procedure was completed with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-09844 |
| MDR Report Key | 7988360 |
| Date Received | 2018-10-21 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2018-10-21 |
| 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 | 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 | GPS III MINI PLATELET CONCENTRATE SEPARATION KIT |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2018-10-21 |
| Model Number | N/A |
| Catalog Number | 800-0505A |
| Lot Number | NI |
| 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 | 1. Required No Informationntervention | 2018-10-21 |