MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS III PLATELET CONCENTRATION SYSTEM; SUPPLIES, BLOOD BANK

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discarded at the user facility.

Event Description

It was reported that the concentration system prp tube 60ml was defective.When the patient¿s blood was placed into the tube and placed into the centrifuge the compartments in the tube leaked and did not separate the specimen properly.Patient¿s blood specimen was not viable.Patients¿ blood was taken again and placed in another concentration system prp tube 60ml.Once the blood entered the tube the compartments began to leak again.The blood was then drawn from the tube ad placed into another platelet concentration prp 60ml tube from another lot number where processing was complete.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of complaint history determined no further action(s) is/are required.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

It was reported that 2 tubes from the concentration system prp tube 60ml 6-pack internally leaked from one compartment into another.When the patient¿s blood was placed into the first tube and placed into the centrifuge, the compartments in the tube leaked and did not separate the specimen properly.Patient¿s blood specimen was not viable.Patients¿ blood was taken again and placed in another tube from the same package.Once the blood entered the tube, the compartments began to leak in the same manner.The blood was then drawn from the tube and placed into another platelet concentration prp 60ml tube from another lot number where processing was complete.The procedure was extended by more than 30 minutes.Attempts have been made and no further information is available at this time.

• Brand Name: GPS III PLATELET CONCENTRATION SYSTEM
• 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: 7428612
• MDR Text Key: 105391782
• Report Number: 0001825034-2018-02552
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PBK070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/21/2022
• Device Model Number: N/A
• Device Catalogue Number: 800-1006A
• Device Lot Number: 645770
• Other Device ID Number: (01) 00880304641068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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: 69 YR