MAUDE Adverse Event Report: BECKMAN COULTER COULTER ISOTON 4 DILUENT; DILUENT, BLOOD CELL

Catalog Number 8547148

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/04/2014

Event Type  malfunction  

Event Description

The customer reported pressure/vacuum background check, hemoglobin (hgb) high, and high vacuum low system errors involving the coulter® hmx hematology analyzer with autoloader.The customer performed system diagnostics with beckman coulter customer technical support (cts) via the telephone but was unsuccessful.There were no erroneous patient results generated at the time of the event.Patient care was not impacted.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The field service engineer (fse) replaced the white blood cell (wbc) bath housing and verified instrument performance.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, the likely cause of the event is attributed to the white blood cell (wbc) bath housing component.Beckman coulter continues to track and trend any incident related to this issue.(b)(4).

Manufacturer Narrative

Based on root cause, the suspect product was identified to be the reagent(s) used with the instrument.Subsequent products are provided here; it is unknown which lots were in use at the time of the event.Therefore, expiration date and device manufacturing date are also unknown for this event.Brand name: coulter isoton iii diluent; catalog #: 8546733; lot #: 50793f through 50818f.Brand name: coulter isoton 4 diluent; catalog #: 8547148; lot #: 18206f.Brand name: coulter lh series diluent; catalog #: 8547194; lot #: 510409f through 510657f; m405237 through m503553.The manufacturing site address has been updated to correlate to the product.New information about the root cause was completed on 8/12/2015.Root cause changed the 510k to exempt to correlate to the product.(b)(4).A recall was completed and an important product notice letter was sent to customers on 09/09/2015.The root cause has been identified as lot to lot variation in the sodium sulfate used in the reagent, which resulted in a compromised white blood cell (wbc) bath in this event.In addition, the investigation found that the root cause identified would not cause or contribute.

• Brand Name: COULTER ISOTON 4 DILUENT
• Type of Device: DILUENT, BLOOD CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN_COULTER; 7381 empire drive; florence KY 41042
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-s08; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 3785607
• MDR Text Key: 4359539
• Report Number: 1061932-2014-00986
• Device Sequence Number: 1
• Product Code: GIF
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8547148
• Device Lot Number: 18206F
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 05/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• 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