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 2013-09-18 for manufactured by .
[3873006]
No adverse event has been reported to keymed ltd and there has been no device malfunction of a keymed product. The olympus keymed ofp-2 flushing pump is a peristaltic pump which has been designed to be used with olympus tube sets (the maj-1608 auxiliary water channel tube/maj-855 auxiliary water tube) and olympus gastrointestinal/ colono/ultrasound endoscopes to facilitate washing of tissues to remove blood, faeces and other organic matter, enabling improved visualisation, diagnosis and therapy during endoscopic procedures. The maj-855 auxiliary water tube comprises a one way (back flow) valve so that water can only flow from the water container to the endoscope. Following an adverse event at the (b)(6) hospital, where it was reported that the luer connector of the maj-855 auxiliary water tube, which incorporates a one way valve, was 'replaced with a homemade stainless steel copy without a one way valve'. This configuration allowed fluid to flow back into the sterile water container. The outcome was potential cross contamination and the hospital recalled 1800 pts. Olympus keymed have been informed that a third hospital in the (b)(6) are using an olympus ofp-2 flushing pump system with unspecified non-olympus tubing which does not contain a one way valve. We have been advised that the (b)(6) has been in contact with the ((b)(6)) and that the (b)(6) have indicated that the risk of (b)(6) is zero and that the hosp do not have to recall pts. Please refer to mfrs report #9611174-2013-00008 for full details of the second hospital in the (b)(6) using tubing without a one way valve with the ofp-2 system. Having received info that three different hospitals (within one market) are not using the ofp-2 flushing pump system in accordance with the instructions for use, ie. Adulterating the maj-855 tubing and removing the 'one way' valve protection, it is possible that other facilities may also have inappropriately modified / removed the maj-855 tubing leading to potential backflow of fluid and pt cross infection. Olympus keymed have decided to raise this mdr report in an abundance of caution and also send an advisory note to all ofp flushing pump users of the consequence of using the pump outside of its intended use. This report is submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[11149001]
Type of reportable event - other: potential pt cross infection. This report is submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2013-00010 |
| MDR Report Key | 3397055 |
| Report Source | 05,06,07 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-08-22 |
| Date of Event | 2013-08-19 |
| Date Mfgr Received | 2013-08-22 |
| Date Added to Maude | 2013-11-13 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALISON PRIOR, RA MGR |
| Manufacturer Street | STOCK RD. SOUTHEND ON SEA |
| Manufacturer City | ESSEX SS2 5QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5QH |
| Manufacturer Phone | 1702616333 |
| Manufacturer G1 | MEDICAL DEVICE MFG CTR |
| Manufacturer Street | JOURNEYMAN'S WAY TEMPLE FARM INDUST ESTATE |
| Manufacturer City | SOUTHEND-ON-SEA, ESSEX S2 5TF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | S2 5TF |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FEQ |
| Date Received | 2013-09-18 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-18 |