MAUDE Adverse Event Report: HALYARD - IRVINE EASYPUMP C-BLOC RA PCA & SAF 2-14: 400ML, 2-14ML/HR + 5ML/30 MIN; ELASTOMERIC PUMP

Model Number 4440008

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Event Description

Fill volume: ni; flow rate: 4ml/hr then 0 ml/hr; procedure: ni; cathplace: ni.An international distributor relayed a report received from a customer in (b)(6) of a patient that experienced cardiac arrest while using a pump.The pump's flow rate was initially set at a 4ml/hr.In less than 2 hours into the infusion, the patient was in cardiac arrest and had to be resuscitated and intubated.The patient was given atropine and adrenaline.It was reported that the patient recovered and was conscious and talking at the time of this report.The nurse removed the pump and set the flow rate to 0ml/hr, however, the nurse observed "dripping." it was further reported, "it is believed that the flow was up to programmed." a pump was available for return.Additional information was requested, however is not available at this time.

Manufacturer Narrative

Cardiac arrest; device operates differently than expected.Method: the partially full used device was received for analysis.A visual inspection and a review of the device history record (dhr) were performed.Results: there are no testing results available as the investigation and evaluation are currently in progress.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.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.

Manufacturer Narrative

Methods: actual device was received for an evaluation and investigation.A visual inspection, flow rate accuracy test and pressure pot testing were conducted.Results: a visual inspection found that the pump was returned partially full.The pinch clamp was opened and the pump infused at all selectable flow rates.The patient controlled analgesia (pca) device was allowed to refill for a few minutes and the button was depressed and functioned appropriately.This was repeated a few times; the bolus button latched properly and dispensed the medication with the bolus device having no issues refilling.The pump was drained and then refilled to the nominal fill volume of 400ml.Flow accuracy testing was performed with the select-a-flow (saf) set to 4ml/hr.After 75 hours of testing, the pump yielded a flow rate that was within specifications with a +/- 20% tolerance.Pressure pot testing was performed on the saf unit's flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr without the filter.The saf unit was detached from the pump.The saf unit was connected to a pressure gauge.Each of the saf flow rates yielded a flow rate that was within specifications with a +/-20% tolerance.Functional testing was performed on the bolus button.The bolus device was attached to the pressure gauge.The bolus button safety test results yielded an average delivery amount that was within specifications.The bolus volume test results yielded an average delivery amount that was within specifications.Conclusions: the investigation summary concluded that fast flow was not observed.During the flow accuracy test, the pump met specifications.During pressure pot testing, all flow rates met specifications using the average bladder pressure.The safety and bolus button tests all met specification and the pca device functioned correctly.As limited information was provided regarding use conditions, it cannot be determined if the device was used in accordance with the instructions for use.The instructions for use (ifu) specifies the following: flow rates may vary due to fill volume, viscosity and/or drug concentration, pump position, temperature, storage, and external pressure."total flow rate refers to bolus + basal rate.To reduce potential adverse effects, medication dosing should be based on the total flow rate.Medications or fluids must be administered per instructions provided by the drug manufacturer.Physician is responsible for prescribing drug based on each patient¿s clinical status (such as age, body weight, disease state of patient, concomitant medications, etc.).It is the responsibility of the healthcare provider to modify patient guidelines provided with the pump as appropriate for your patients¿ clinical status and medication prescribed.To avoid complications, use the lowest flow rate, volume and drug concentration required to produce the desired result.An historical review indicated that no other complaints were reported for this reported incident and related to the same lot number.A technical bulletin ((b)(4)), factors affecting flow rate, was sent to the customer.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: EASYPUMP C-BLOC RA PCA & SAF 2-14: 400ML, 2-14ML/HR + 5ML/30 MIN
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 2211 6
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4770289
• MDR Text Key: 5948759
• Report Number: 2026095-2015-00149
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 4440008
• Device Catalogue Number: 101353100
• Device Lot Number: 0201425493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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
• Patient Outcome(s): Life Threatening; Required Intervention