MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for GPS III PLATELET CONCENTRATION SYSTEM N/A UNK GPS III MINI KIT manufactured by Zimmer Biomet, Inc..
[90305308]
Although product was not returned for evaluation and thus a root cause could not be confirmed, upon discussion with the sales rep and the product manager, it was determined that the likely root cause of this event was due to an air escape port on the top of the device. The person injecting the blood must have had their finger over this valve and caused the device to fill with air and build pressure. When the syringe was detached, pressure was released and blood squirted out of the syringe port. Part and lot identification necessary for review of device history records, and complaint history was not provided. It was determined that lot number would not add value to this investigation as the event was user error. Relayed completion of the investigation to the sales rep via email on january 6, 2015. 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
[90305309]
It was reported the patient went to a doctor's office on (b)(6) 2014 to receive a prp injection for better healing in the achilles tendon. No implant was put in prior to this. After the patient's blood was plunged into the gps mini kit, they unscrewed the syringe from the gps tube and blood squirted back out from where the syringe was plunged in. It is believed the air escape port on top of the device was somehow covered. This caused the device to fill with air and pressure to build up. When the syringe was detached, the pressure was released by squirting blood out of this port. The patient left and went to a different office the next day to receive the prp injection. A different gps mini kit was used to complete the procedure on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-08321 |
| MDR Report Key | 6934070 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date of Event | 2014-10-15 |
| Date Mfgr Received | 2014-10-22 |
| Date Added to Maude | 2017-10-10 |
| 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 PLATELET CONCENTRATION SYSTEM |
| Generic Name | INSTRUMENT - BIOLOGICS |
| Product Code | KSS |
| Date Received | 2017-10-10 |
| Model Number | N/A |
| Catalog Number | UNK GPS III MINI KIT |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-10-10 |