MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-09-14 for GPSIII 30 W/ACDA JP N/A 800-1012 manufactured by Zimmer Biomet, Inc..
[120256115]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. 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)(6) manufactures a similar device in the united states under 510k number bk070026.
Patient Sequence No: 1, Text Type: N, H10
[120256116]
It was reported that when the gps was put through the cycle in the centrifuge, the patient's blood would not properly separate. Additional blood had to be drawn from the patient due to the malfunction.
Patient Sequence No: 1, Text Type: D, B5
[134247918]
Report source: (b)(6). Complaint sample was evaluated and the reported event was confirmed. Inspection of the returned device revealed that the blood inside the kit is black. Device history record was reviewed and no discrepancies were found. The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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
[134247919]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-08894 |
| MDR Report Key | 7876424 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-09-14 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2018-09-14 |
| 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 | GPSIII 30 W/ACDA JP |
| Generic Name | SUPPLIES, BLOOD BANK |
| Product Code | KSS |
| Date Received | 2018-09-14 |
| Returned To Mfg | 2018-10-01 |
| Model Number | N/A |
| Catalog Number | 800-1012 |
| Lot Number | 602372 |
| Device Expiration Date | 2019-11-30 |
| 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 | 1. Required No Informationntervention | 2018-09-14 |