MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN SAPPHIRE ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H00-01

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in process.

Event Description

During replacement of cell dyn sapphire analyzer v135 fitting tubing, the customer was splashed in the face and eye with liquid.The customer stated that the analyzer was in disable mode at the time of the incident, however the customer was not wearing a face shield or goggles.The customer stated that they washed their face with water.On the day of the occurrence, there was some redness of the skin.The redness went away after the individual showered, and no pain or other irritation was reported.No medical treatment was provided.

Manufacturer Narrative

An abbott field service representative (fsr) was dispatched to the account and replaced the leaking fitting (kit srv fluidic fitting cdsphr rohs part 8913057102) on the cell dyn sapphire analyzer.The fsr additionally replaced the chopper driver board for the aspiration pump (pcb assy, chopper driver mod, cdsphr part 8960042701) to resolve the aspiration errors observed by the customer.The analyzer was returned to normal operation.Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a labeling review.No returns were made available from the customer site for this evaluation.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.When the incident occurred, the customer stated they were not wearing protective eye wear.Per the cell-dyn sapphire system operator manual, section 8.Hazards, wearing proper personal protective equipment (ppe) are recommended safety practices, and the manual includes instructions to wear impervious gloves, protective eye wear and clothing when handling biological or chemical hazards.Global service and support (gss) reviewed the issue.Gss stated that the replaced fitting associated with the incident is only used to transport hgb reagent from the hgb syringe.Blood samples do not pass through the affected line.The hgb reagent contains imidazole, sodium hydroxide, and surfactant.Labeling of the reagent includes instructions to wear protective gloves, protective clothing, and eye protection.Additionally, gss stated the amount of reagent capable of splashing from the t-fitting at the time of the incident may have been minimal because the analyzer was in standby mode.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6761436
• MDR Text Key: 81801474
• Report Number: 2919069-2017-00122
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

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: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/02/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1