MAUDE Adverse Event Report: HALYARD-IRVINE ON-Q PUMP 400ML,5ML/HR + 5ML/60 MIN ONDEMAND; ELASTOMERIC PUMP

Model Number CBI003

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Fill volume: 200ml.Flow rate: 5ml/hr.Procedure: orthopedic surgery to cruciate ligaments.Cath place: asku.It was reported that an incident of a device misuse occurred at an international hospital while using a pump.It was reported that on (b)(6) 2015 a pump's bolus button was "blocked." the nurse clamped the device to stop the infusion and requested further information about the use of the device.On (b)(6) 2015, it was further reported that the misuse of device was due to the instructions on the red tab being in a foreign language and that the (b)(6) speaking nurse incorrectly interpreted the instructions on the red tab to be "do not remove".Furthermore, it was reported that the misuse of the device occurred when the nurse filled the pump to 200ml instead of the labeled volume 400ml.Additional information was received on (b)(6) 2015.It was clarified that the nurse did not remove the red priming tab prior to use.Additional information was received on (b)(6) 2015.It was reported that the device was not kept, thus unavailable for return.The patient age, gender and weight were not reported.No patient injury nor medical intervention were reported.Additional information was requested, however is not available at this time.

Manufacturer Narrative

(b)(4).Method: the device will not be returned for an analysis.The lot number was not reported; therefore, a review of the device history record (dhr) was unable to be performed.However, a use review was conducted.Results: as no device was available for an evaluation, no device testing methods were performed and results cannot be obtained.However, the use review recounted that it was reported that the bolus button on the on demand device of the on-q pump was ¿blocked.¿ the nurse clamped the line to prevent continuous over delivery of medication.It was reported that there was a misuse of the device due to instructions being written in a foreign language.The tab on the red priming key which instructs users to remove after priming is written in english only; however the customer is(b)(6) speaking.The red priming key tab was never removed before attaching the pump to the patient.In addition, the pump was filled to 200ml instead of 400ml.The instructions for use (ifu) specifies, "warning: do not pull the red tab upwards as breakage could occur"."if red tab is not removed or breaks while removing, continuous delivery will occur.This delivery may be significantly greater than the total flow rate (bolus + basal)." the ifu also specifies, ¿warning" "on demand* device: to prevent continuous over delivery of medication significantly greater than the total flow rate, close the clamp if any of the following conditions occur: ¿ the red tab is not removed or breaks while removing." the ifu also specifies, ¿caution: do not underfill pump.Underfilling pump may significantly increase the flow rate.¿ conclusions: the device was not returned to (b)(4) for an evaluation.However, the instructions for use (ifu) is offered in multi-languages, including (b)(4).The red priming key tab was never removed before attaching the pump to the patient.In addition, the pump was filled to 200ml instead of 400ml.Per the ifu caution, "do not underfill pump.Underfilling pump may significantly increase the flow rate.¿ per the ifu warning, "if red tab is not removed or breaks while removing, continuous delivery will occur." the nurse clamped the line to prevent continuous over delivery of medication, as instructed in the ifu.No patient injury nor medical intervention were reported.Based on the reported information, the failure to follow instructions may have contributed to the reported incident.The day after the reported incident a representative went to the facility to follow-up on the instructions for use with the facility.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 400ML,5ML/HR + 5ML/60 MIN ONDEMAND
• 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: 4629079
• MDR Text Key: 5572849
• Report Number: 2026095-2015-00110
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/26/2015

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: Nurse
• Device Model Number: CBI003
• Device Catalogue Number: 101348000
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/24/2015
• 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