MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2018-04-13 for GPS III PLATELET CONCENTRATION SYSTEM N/A 800-1006A manufactured by Zimmer Biomet, Inc..
[105391782]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded at the user facility.
Patient Sequence No: 1, Text Type: N, H10
[105391783]
It was reported that the concentration system prp tube 60ml was defective. When the patient? S blood was placed into the tube and placed into the centrifuge the compartments in the tube leaked and did not separate the specimen properly. Patient? S blood specimen was not viable. Patients? Blood was taken again and placed in another concentration system prp tube 60ml. Once the blood entered the tube the compartments began to leak again. The blood was then drawn from the tube ad placed into another platelet concentration prp 60ml tube from another lot number where processing was complete. Attempts have been made and no further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-02552 |
| MDR Report Key | 7428612 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2018-04-13 |
| Date of Report | 2018-05-02 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-04-13 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | GPS III PLATELET CONCENTRATION SYSTEM |
| Generic Name | SUPPLIES, BLOOD BANK |
| Product Code | KSS |
| Date Received | 2018-04-13 |
| Model Number | N/A |
| Catalog Number | 800-1006A |
| Lot Number | 645770 |
| ID Number | (01) 00880304641068 |
| Operator | PHYSICIAN |
| 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 | 2018-04-13 |