MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for SET 60DROP STAT2 SPLIT SEP S2V-60 manufactured by Conmed Corporation.
[77616861]
The user facility, (b)(6) hospital, reported the device was not allowing fluid/drugs to drip properly. The device was returned, flow rate was tested during evaluation and the complaint was not confirmed. The device was able to regulate flow consistently, turn off and run full open properly. Variation in drip rate is expected with this product. The instruction for use cautions the user that dial numbers are approximate. Medical professionals should confirm drip rate by using timer or watch with a second hand. The product specification states there must be a continuous increase in flow rate when the dial is turned from off to full. This device met specification. The complaint product was re-evaluated as part of a root cause investigation on 08 jun 2017. Engineers disassembled the item to evaluate the internal drum. The drum channel was incorrect and is being addressed with a supplier corrective action request. Based on these findings, this complaint is considered confirmed and supplier related.
Patient Sequence No: 1, Text Type: N, H10
[77616862]
The user facility reported the device was not allowing fluids/drugs to drip properly. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00137 |
| MDR Report Key | 6636866 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-13 |
| Date Mfgr Received | 2017-06-08 |
| Device Manufacturer Date | 2015-07-14 |
| Date Added to Maude | 2017-06-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SET 60DROP STAT2 SPLIT SEP |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | LDR |
| Date Received | 2017-06-13 |
| Returned To Mfg | 2015-11-20 |
| Catalog Number | S2V-60 |
| Lot Number | 201507144 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |