MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPSIII 30 W/ACDA JP; SUPPLIES, BLOOD BANK

Model Number N/A

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Code Available (3191)

Event Date 08/15/2018

Event Type  Injury  

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.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)(6) manufactures a similar device in the united states under 510k number bk070026.

Event Description

It was reported that when the gps was put through the cycle in the centrifuge, the patient's blood would not properly separate.Additional blood had to be drawn from the patient due to the malfunction.

Manufacturer Narrative

Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the blood inside the kit is black.Device history record was reviewed and no discrepancies were found.The 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 further event information available at the time of this report.

• Brand Name: GPSIII 30 W/ACDA JP
• 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: 7876424
• MDR Text Key: 120256115
• Report Number: 0001825034-2018-08894
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 800-1012
• Device Lot Number: 602372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR