MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPSIII 60 W/ACDA JP; SUPPLIES, BLOOD BANK

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 11/21/2018

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.Product not returned.

Event Description

It was reported that surgeon could not abstract prp after centrifugation.Subsequently, the patient blood was re-drawn to complete the procedure with another gps kit.As a result, there was a delay of 16-30 minutes.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  complaint sample was evaluated and the reported event confirmed.The reported device was returned and evaluated.There were 2 blood clots in the tube.There is blood (prp) in the gps assembly above the buoy that is not congealed and below the buoy is blood that is congealed.None of the ports appear to be damaged device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.  a summary of the investigation has been sent to the complainant.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: GPSIII 60 W/ACDA JP
• Type of Device: SUPPLIES, BLOOD BANK
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8163906
• MDR Text Key: 130323925
• Report Number: 0001825034-2018-11091
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 800-1013
• Device Lot Number: 801926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention