MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A N/A 800-1012 manufactured by Zimmer Biomet, Inc..
[118094666]
(b)(4). Foreign - event occurred in (b)(6). This product is manufactured by zimmer biomet us and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under 510k number k070026. The complaint device is reportedly in process of being returned to zimmer biomet for evaluation. Once the evaluation is completed, a supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[118094667]
It was reported that during a procedure where blood was being separated utilizing the gps system, the platelet poor plasma (ppp) and platelet rich plasma (prp) did not separate as intended. Another kit was utilized to successfully complete the procedure. No patient consequences were reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
[125688096]
(b)(4). This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of actual product received and photos received by customer. The blood is a darker red color confirming that it did not properly separate as intended; therefore, the complaint is confirmed. Device history record (dhr) review was performed with no deviations or anomalies. Root cause could not be determined. If any further information is found which would change or alter any information or conclusions, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[125688097]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-08470 |
| MDR Report Key | 7807040 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-10-09 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2018-08-22 |
| 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 | GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2018-08-22 |
| Returned To Mfg | 2018-09-07 |
| Model Number | N/A |
| Catalog Number | 800-1012 |
| Lot Number | 601564 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-08-22 |