MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS MINI KIT W /ACD-A & BD; BIOLOGICS, INSTRUMENTS

Catalog Number 800-0670A

Device Problem Separation Problem (4043)

Patient Problem No Information (3190)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

(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.Report source: the event occurred in (b)(6).

Event Description

It was reported that during the procedure, the blood did not separate in the device.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h4, h6, h10.Visual inspection of the returned tube noted some of the liquid, inside of the tubes has hardened with some still remaining in a liquid state.No further evaluation could be performed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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 further event information available at the time of this report.

• Brand Name: GPS MINI KIT W /ACD-A & BD
• Type of Device: BIOLOGICS, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9079162
• MDR Text Key: 159156145
• Report Number: 0001825034-2019-04166
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 800-0670A
• Device Lot Number: 802326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1