MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS III SINGLE KIT W/30ML ACDA; INSTRUMENT, BIOLOGICS

Catalog Number	800-1003A
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 or Problem Description
It was reported approximately three (3) months ago, a standard gps kit was used in a clinical setting.After the spin, the canister was removed from the centrifuge and the blood was not separated correctly.The kit was discarded and not used on the patient.
Event or Problem Description
No further event information available at the time of this report.
Additional 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; h6.Visual examination of the provided pictures identified the blood did not fully fractionate.Device not returned.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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. .

• Brand Name: GPS III SINGLE KIT W/30ML ACDA
• Common Device Name: INSTRUMENT, BIOLOGICS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10122632
• Report Number: 0001825034-2020-02229
• Device Sequence Number: 19596517
• Product Code: KSS
• UDI-Device Identifier: 00880304681491
• UDI-Public: (01)00880304681491
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BK070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 800-1003A
• Device Lot Number: 190043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1