MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-24 for KARL STORZ 27224P manufactured by Karl Storz Endovision.
[1883816]
Allegedly, at the beginning of a turbt procedure, doctor noticed pump was not suctioning well and some brownish liquid was backing up in the pt. At that time, they examined pump and discovered that someone in the operating room staff had reversed the tubing when they assembled on the pump. They put the suction end into a surgical drain and some material was pumped into pt. Doctor aborted procedure. As a precaution, they put pt on course of antibiotics and contact said there were no adverse effects on the pt noted as a result of this event. Due to pt's underlying medical condition, he was referred to another hospital for the turbt procedure. There was no report of malfunction.
Patient Sequence No: 1, Text Type: D, B5
[9002302]
The unit was not returned because the hospital reported it did not malfunction; they put it back into circulation. Our user instruction manual for the continuous flow pump has warnings that state: caution: the (b)(4) is designed as a low to medium flow suction pump for liquids only. This pump is not to be used as an infusion pump, i. E. , to pump liquid or gas into the pt. Caution: it is extremely important that the tubing be properly connected in the correct direction through the pump head. If the direction of the flow is reversed, the output of the pump will be into the pt which is extremely dangerous. On the pump itself, the inflow/outflow is clearly marked in bright yellow and black directions along with arrows showing the correct direction/orientation when installing tubing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221826-2011-00013 |
| MDR Report Key | 2039513 |
| Report Source | 06 |
| Date Received | 2011-03-24 |
| Date of Report | 2011-03-22 |
| Date of Event | 2011-02-18 |
| Date Facility Aware | 2011-02-23 |
| Report Date | 2011-03-22 |
| Date Reported to FDA | 2011-03-22 |
| Date Reported to Mfgr | 2011-03-22 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2012-06-05 |
| 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 Street | 91 CARPENTER HILL RD. |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | CONTINUOUS FLOW PUMP |
| Product Code | KQT |
| Date Received | 2011-03-24 |
| Model Number | 27224P |
| Catalog Number | 27224P |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | CHARLTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-24 |