MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A; SUPPLIES, BLOOD-BANK

Model Number N/A

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign - event occurred in (b)(6).This product is manufactured by zimmer biomet us and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under 510k number k070026.The complaint device is reportedly in process of being returned to zimmer biomet for evaluation.Once the evaluation is completed, a supplemental mdr will be submitted.

Event Description

It was reported that during a procedure where blood was being separated utilizing the gps system, the platelet poor plasma (ppp) and platelet rich plasma (prp) did not separate as intended.Another kit was utilized to successfully complete the procedure.No patient consequences were reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of actual product received and photos received by customer.The blood is a darker red color confirming that it did not properly separate as intended; therefore, the complaint is confirmed.Device history record (dhr) review was performed with no deviations or anomalies.Root cause could not be determined.If any further information is found which would change or alter any information or conclusions, 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 30ML PLATELET CONCENTRATION KIT WITH ACD-A
• Type of Device: SUPPLIES, BLOOD-BANK
• 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: 7807040
• MDR Text Key: 118094666
• Report Number: 0001825034-2018-08470
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 800-1012
• Device Lot Number: 601564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1