MAUDE Adverse Event Report: BECKMAN COULTER ALLEGRA X-5 CENTRIFUGE; CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Catalog Number B30590

Device Problems Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Not Applicable (3189)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) visited the site on (b)(4) 2016.Per the service report, the instrument was removed and a loaner instrument was installed at the customer site.A known issue identified by the supplier (incorrect rotor geometry due to a manufacturing defect) contributed to this event.The loading pattern used by the customer also contributed to the rotor becoming imbalanced.The imbalanced rotor caused the reported event.(b)(4).

Event Description

The customer reported that their allegra x-5 centrifuge emitted unusual sounds during a run and vibrated, falling off of the bench.No sparks, smoke, or flames were present.There was no death, injury, or effect to patient results associated with this event.

• Brand Name: ALLEGRA X-5 CENTRIFUGE
• Type of Device: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5454829
• MDR Text Key: 38824074
• Report Number: 3007448124-2016-00004
• Device Sequence Number: 1
• Product Code: JQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B30590
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1