MAUDE Adverse Event Report: HOLOGIC INC THINPREP 5000 PROCESSOR; THINGPREP 5000 PROCESSOR

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

A customer in (b)(6) reported an occurrence of their thinprep 5000 instrument taking too much fluid out of the vials and loosing quite a bit of fluid between the vial and the slide, and there is not enough cells on the cell spot.They have had to recall pts for sampling.Hologic field service engineer (fse) was dispatched.Hologic field service engineer confirmed and was able to reproduce the error.While servicing the instrument the fse found the rotary vane pump to be the most likely cause of the error.Fse replaced pump to resolve the error.Processed samples to confirm operation.Instrument operations.Hs: this is a reportable event since the thin prep 5000 processor did not perform as intended and the pt needed to be recalled for additional sample collection, which resulted in a delay in pt diagnosis.(b)(6): per the current version of the (b)(6) guidelines, we would not classify this as a reportable event in the eu.There was no injury or misdiagnosis.The reported issue was determined to be a technical nature issue and was successfully reproduced and resolved following field service engineer intervention.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINGPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC INC; marlborough MA 01752
• Manufacturer Contact: eva maxwell ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 4264364
• MDR Text Key: 5106576
• Report Number: 1222780-2014-00188
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2014
• 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