MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS III PLATELET CONCENTRATION SYSTEM; INSTRUMENT - BIOLOGICS

Model Number N/A

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 10/15/2014

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: GPS III PLATELET CONCENTRATION SYSTEM
• Type of Device: INSTRUMENT - BIOLOGICS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6934070
• MDR Text Key: 90305308
• Report Number: 0001825034-2017-08321
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK GPS III MINI KIT
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 91