MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CENTRIFUGE 115V 50/60HZ DRUCKR; BLOOD WORK SUPPLIES

Catalog Number 755VES

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdrs were filed for this event.Please see associated: 0001825034 - 2019 - 00763.The device has been returned and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the centrifuge malfunctioned causing the balancing to be off, not allowing for an accurate spin.This was identified in an office setting; no patient or surgical involvement.No further information is available at the time of this reporting.

Manufacturer Narrative

Reported event was confirmed via visual examination of the returned device.The device exhibits damage consistent with use over time.Dhr was reviewed and no discrepancies were found.Root cause is attributed to wear out due to normal use.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 information available at the time of this reporting.

• Brand Name: CENTRIFUGE 115V 50/60HZ DRUCKR
• Type of Device: BLOOD WORK SUPPLIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8357746
• MDR Text Key: 136766907
• Report Number: 0001825034-2019-00771
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 755VES
• Device Lot Number: 150660AA113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 755VES CENTRIFUGE LOT 60120511; 755VES CENTRIFUGE LOT 60120511