MAUDE Adverse Event Report: HALYARD-IRVINE ON-Q PUMP SELECT-A-FLOW; ELASTOMERIC PUMP

Model Number ASKU

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2008

Event Type  malfunction  

Event Description

Fill volume: asku.Flow rate: asku.Procedure: asku.Cathplace: asku.It was reported that a pump "free flowed into a patient".There was no report of patient injury nor medical intervention required.Additional details regarding the event have been requested, but are not available at this time.

Manufacturer Narrative

(b)(4).Method: the device is not available for return.Information on the model and lot number was requested, however is not available at this time; a review of the device history record (dhr) cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Conclusions: limited information was provided by the reporter.It was reported that the pump was either a cb004 or a cb6004.The incident occurred in 2008.Since the device was not returned to halyard for evaluation, we are unable to determine the cause for the reported event.A variety of factors such as fill volume, temperature, pump position and storage times may affect the flow rate accuracy of elastomeric pumps.These factors may result in an increase or decrease in flow rate from the labeled flow rate and impact the delivery time.The instructions for use (ifu)(1304513)specificies, "cautions the amount of medication over the therapeutic period and delivery time can vary by as much as 20% due to the flow rate variation.""do not underfill pump.Underfilling the pump may significantly increase the flow rate.Filling the pump less than nominal results in faster flow rate." "temperature will affect solution viscosity, resulting in faster or slower flow rate." the ifu also specifies, "when filled to nominal volume, flow accuracy is +/- 20% of the labeled flow rate when the infusion is started 0-8 hours after fill and delivering normal saline as a diluent at 22 degrees c, 72 degrees f." information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q PUMP SELECT-A-FLOW
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD-IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4610945
• MDR Text Key: 5658253
• Report Number: 2026095-2015-00092
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2015

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
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1