MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-02-13 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[67294504]
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).
Patient Sequence No: 1, Text Type: N, H10
[67294705]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00024 |
| MDR Report Key | 6327263 |
| Report Source | FOREIGN |
| Date Received | 2017-02-13 |
| Date of Report | 2017-01-16 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2017-02-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-13 |