MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Device Reprocessing Problem (1091); Device Displays Incorrect Message (2591)

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

Event Type  Injury  

Manufacturer Narrative

For this investigation error 6306 (failed to evacuate filer) was reported.The filter seal was cleaned to restore the instrument to full operation.If the filter seal leaks from contamination the 6306 error is generated since the filter cannot be evacuated without a perfect seal.The seal is a high maintenance item requiring frequent cleaning to function reliably.No other related issues have been reported since the field service.This was a preventive maintenance/cleaning issue, not an equipment defect.Device history record (dhr) review was conducted for the identified serial number of the device.No abnormalities were found.This instrument passed final testing prior to release.(b)(4).

Event Description

A customer in (b)(6) reported their thinprep 5000 processor produced an error code 6306- failed to evacuate filter on the instrument.The customer confirmed that because half of the liquid on the vial has been used, the sample is compromised and cannot be used to reprocess.This was the only error on the batch.Hologic technical support (ts) asked the customer to clean the filter plug, check for damage in the tubing, empty the waste bottle and power cycle the instrument.The customer called back ts and confirmed the instrument is operating properly.No further issue since the troubleshooting.Customer also confirmed that the recall is needed for the lost sample.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6327263
• MDR Text Key: 67294504
• Report Number: 1222780-2017-00024
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 950039/S26
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/13/2017
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other