MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL,

Model Number N/A

Device Problems Device Displays Incorrect Message (2591); Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was dispatched on 09/23/2015.The field service engineer (fse) confirmed that the instrument had generated partial aspiration errors.He found that the partial aspiration errors were caused by a failure of the blood sampling valve (bsv).The fse replaced the bsv which resolved the partial aspiration errors.The instrument ran without leaks and all repairs were verified per established service procedures.(b)(6).

Event Description

The customer reported an aspiration issue was observed on the coulter lh 750 hematology analyzer while performing normal routine operation.The customer stated that partial aspiration error messages had been generated at the time of the event.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection with the event.There was no impact to patient results or controls.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL,
• 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 2031
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 5163319
• MDR Text Key: 28982298
• Report Number: 1061932-2015-01577
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061574
• 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
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• 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: 6605632
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2009
• 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