MAUDE Adverse Event Report: CONMED CORPORATION SET 60DROP STAT2 SPLIT SEP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	S2V-60
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The user facility reported the device was not allowing fluids/drugs to drip properly.No additional information was provided.

• Brand Name: SET 60DROP STAT2 SPLIT SEP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6636866
• Report Number: 3007305485-2017-00137
• Device Sequence Number: 19113136
• Product Code: LDR
• UDI-Device Identifier: 00653405033014
• UDI-Public: (01)00653405033014(17)20071230110201507144
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K905498A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/12/2020
• Device Catalogue Number: S2V-60
• Device Lot Number: 201507144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/13/2017
• Patient Sequence Number: 1