MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS III MINI PLATELET CONCENTRATE SEPARATION KIT; SUPPLIES, BLOOD-BANK

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number - (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discarded.

Event Description

It was reported that during an office injection the blood was spun in the centrifuge and the blood did not separate.The surgeon believed that the buoy failed to spin and didn't separate.The procedure had to be stopped.Approximately a week later on an unknown date, the patient's blood was re-drawn and the procedure was completed with another device.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Event Description

No additional information received.

• Brand Name: GPS III MINI PLATELET CONCENTRATE SEPARATION KIT
• Type of Device: SUPPLIES, BLOOD-BANK
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7988360
• MDR Text Key: 124476991
• Report Number: 0001825034-2018-09844
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• PMA/PMN Number: BK070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 800-0505A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention