MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GPS MINI KIT WITH ACD-A & BD -A/BLOOD D; SUPPLIES, BLOOD-BANK

Catalog Number 800-0670A

Device Problem Separation Problem (4043)

Patient Problem No Information (3190)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign - (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the device did not remove enough plasma.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified there is dried blood in the canister.There are no blockages in the silicone coiled tube.The ports are not damaged or cracked.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: GPS MINI KIT WITH ACD-A & BD -A/BLOOD D
• Type of Device: SUPPLIES, BLOOD-BANK
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8662532
• MDR Text Key: 146794329
• Report Number: 0001825034-2019-02404
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• PMA/PMN Number: BK070026
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 800-0670A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1