MAUDE Adverse Event Report: BECKMAN COULTER POWER VAR UNINTERRUPTIBLE POWER SUPPLY; COUNTER, DIFFERENTIAL CELL

Model Number ABCE1442-11

Device Problem Temperature Problem (3022)

Patient Problem Not Applicable (3189)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

The information provided reasonably suggests that the event occurred on equipment that is not manufactured by beckman coulter inc.The cause of the powervar® failure cannot be determined based on the information available.The connected dxh 600 analyzer did not cause or contribute to this event.The customer was provided with a new uninterruptible power supply (ups) and there have been no further reported issues.The failed ups was requested from the customer but has not been delivered to the manufacturer.In an abundance of caution, bec is filing an mdr for this event based on the reported injury.(b)(4).

Event Description

The customer reported a burning smell coming from the uninterruptible power supply (ups) connected to the unicel dxh 600 coulter cellular analysis system.In addition the customer reported that an operator had an asthma attack because of the smell.The operator then used her inhaler and went home for the day following the event.She returned to work the following day and stated that her at-home nebulizer was also used, however she did not seek medical attention.There was no smoke, arc, sparks or flames reported by the customer.The fire department was not called and the fire extinguisher was not used.Erroneous results were not generated and there was no change in patient treatment in connection with this event.

Manufacturer Narrative

Per supplemental analysis of the inspected device provided by the manufacturer, when power was applied to the ups, the batteries were in a defective state and swelled.The unit will charge the battery that is weakened, this leads to failure in the battery, causing the battery to exceed battery design limits causing expansion and venting.

• Brand Name: POWER VAR UNINTERRUPTIBLE POWER SUPPLY
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): INTELLIGENT POWER SOLUTIONS INC.; 741 n. main street; orange CA 92868
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th ave; 32-s08; miami 33196 ; 3053802031
• MDR Report Key: 6594152
• MDR Text Key: 76061387
• Report Number: 1061932-2017-00005
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABCE1442-11
• Device Catalogue Number: B79859
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other