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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number ¿ the lot number cannot be confirmed, however, is likely one of 701805, 801851, 801854, 802306, or 802556.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.

Event Description

It was reported that during a procedure utilizing a platelet concentrate separator kit, the platelet rich plasma (prp) appeared paler than normal and, when attempting to inject, the surgeon was unable to use push the syringe plunger.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Lot number - 801851 or 801854.Product was returned and evaluated.The blood in the syringe is observed to be paler in color than expected.The complaint is confirmed, however, based on the whether the patient had fasted prior to the procedure and the lipid content (creates slight variation in plasma density) in the blood the red cell count will vary causing differences in the appearance of the device output therefore, the device operated within specification review of device history records found these units were released to distribution with no deviations or anomalies.No failure was detected and the device operated within specification; this event is being reassessed as not a mdr reportable event as there was no device malfunction or injury.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information received.

• Brand Name: GPSIII 30 W/ACDA JP
• Type of Device: CENTRIFUGES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8417764
• MDR Text Key: 138936676
• Report Number: 0001825034-2019-01124
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 800-1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1