MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 03R70-01

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

The customer stated that the cable on the alinity ci series instrument external waste pump that was plugged into the wall socket was scorched and visible smoke was seen in the laboratory.No person or object was damaged or injured.Replacement pump has already been connected and devices are running without any problems.No impact to patient management, user safety was reported.

Manufacturer Narrative

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

Event Description

The customer stated that the cable on the alinity ci series instrument external waste pump that was plugged into the wall socket was scorched and visible smoke was seen in the laboratory.No person or object was damaged or injured.Replacement pump has already been connected and devices are running without any problems.No impact to patient management / user safety was reported.

Manufacturer Narrative

The field service representative (fsr) replaced the alnty ci external waste and observed charring/burning of the electrical cord.Replacement of the part resolved the issue.Return testing was not completed as returns were not available.The instrument service history review for (b)(6) revealed no additional service tickets associated with smoke and scorching/burn observed due to a part.A review of tracking and trending for the alinity ci-series system control module did not identify any trends.A review of tracking and trending for the alnty ci external waste did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity ci-series system control module for serial (b)(6) or the alnty ci external waste were identified.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL MODULE
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18684568
• MDR Text Key: 335206659
• Report Number: 3016438761-2024-00082
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY CI EXTERNAL WASTE, 04S74-01, UNKNOWN; ALNTY CI EXTERNAL WASTE, 04S74-01, UNKNOWN