MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-17 for THINPREP 3000 PROCESSOR manufactured by Hologic, Inc.
[47607863]
A customer in the us reported an instance of their thinprep 3000 processor having a fixative clogged which was resolved by cleaning nozzle with warm water. However, now reports the machine is sucking up all the sample in the vial and not able to make a slide. According to caller, no error code or message is present. System is not usable and taken offline. Hologic field service engineer (fse) dispatched to the customers site. Fse found evacuation valve to be cause of problem. Replaced qto valve as a precaution. Replaced fixative air brush and lee valve for slow flow. All replacements and verifications performed per technical documentation. Ran pneumatic test and blank sample to verify instrument operational. This is a reportable event since the thinprep 3000 processor did not perform as intended and the patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00146 |
| MDR Report Key | 5732118 |
| Date Received | 2016-06-17 |
| Date of Report | 2016-06-15 |
| Date Mfgr Received | 2016-06-02 |
| Date Added to Maude | 2016-06-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EVA MAXWELL |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP 3000 PROCESSOR |
| Generic Name | THINPREP 3000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2016-06-17 |
| 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 | 2016-06-17 |