MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-02-26 for FMS ENDO 99 FMS UROLOGY PUMP UNK UNK FMS PRODUCT manufactured by Depuy Mitek.
[20021090]
A patient was undergoing a "transurethral resection of the prostate" (a cystoscopy) with the use of a fms endo 99 urology pump, a fluid mgmt system. The "inflow" of the pump was setup to the patient's penis (? ). During the procedure, the pump was acting erratically. Allegedly, the inflow of glycerine was too fast, the pressure was 100 and the flow was 200, the pump would go fast, then slow, and then stop. They restarted or reset the pump several times (2-3 times) by passing or overriding the safety stop with the same results. The patient was conscious for the procedure and at some point complained of chest pain and discomfort at which time they stopped using the pump, palpated the patient's abdomen, and found it to be rock hard. The surgeon continued and completed the procedure without use of the pump, and the patient was then moved to the icu and is now in a coma. There is a meeting scheduled at the facility over this event. This is all the information that has been made available to date. There are gaps in the data and the details of the event; however, there are pertinent questions out to our representative to fill in the missing pieces of the story. Our rep will be supplying us with further detail and progress reports, as they are made available.
Patient Sequence No: 1, Text Type: D, B5
[20096299]
Mitek is at this point in time in the information gathering mode. When all that can be had, is had and thoroughly investigated and evaluated, those results will be the subject matter in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2009-00064 |
| MDR Report Key | 1331189 |
| Report Source | 05,06,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2009-02-19 |
| Date of Event | 2009-02-18 |
| Date Facility Aware | 2009-02-18 |
| Report Date | 2009-02-19 |
| Date Reported to Mfgr | 2009-02-19 |
| Date Mfgr Received | 2009-02-19 |
| Device Manufacturer Date | 2009-06-17 |
| Date Added to Maude | 2009-03-10 |
| 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 | MR. ARTHUR FRIGAULT |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089773856 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FMS ENDO 99 FMS UROLOGY PUMP |
| Generic Name | FLUID MANAGEMENT SYSTEM |
| Product Code | KQT |
| Date Received | 2009-02-26 |
| Model Number | UNK |
| Catalog Number | UNK FMS PRODUCT |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DR. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2009-02-26 |