MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-23 for GPS III GRAVITATIONAL PLATELET SEPARATION SYSTEM N/A 800-1006A manufactured by Zimmer Biomet, Inc..
[100883852]
(b)(4). Concomitant medical products: unknown part#, gps iii gravitational platelet separation system, lot 700931, quantity 2. Patient was stuck with needle additional times. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[100883853]
It was reported that when the patient? S blood was drawn into the tube and placed into centrifuge, the compartments on the tube leaked and did not separate the specimen properly. Patient? S blood specimen was not viable. Patient? S blood was taken again and placed in another tube. Once the blood entered the tube the compartments began to leak again. The blood was then drawn from the tube and placed into another tube from another lot number, where processing was complete. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-01395 |
| MDR Report Key | 7293824 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-23 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-01-23 |
| Date Mfgr Received | 2018-05-17 |
| Device Manufacturer Date | 2017-04-13 |
| Date Added to Maude | 2018-02-23 |
| 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 | GPS III GRAVITATIONAL PLATELET SEPARATION SYSTEM |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2018-02-23 |
| Model Number | N/A |
| Catalog Number | 800-1006A |
| Lot Number | 700931 |
| ID Number | (01) 0 0880304 64106 8 |
| 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. Other | 2018-02-23 |