MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14+5,EPCMBO,-,EP,5; ELASTOMERIC - COMBO

Model Number 4440008

Device Problem Infusion or Flow Problem (2964)

Patient Problems Swelling (2091); No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record for the lot number, 0202270796, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and is being processed for evaluation.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: unknown, flow rate: unknown, procedure: left ptg, cathplace: sapphene.A report was received from france stating a fast flow event occurred.Between 6-hours and 8-hours after filling the device, a fast flow of the of local anesthetic occurred.At day-one, post procedure, the rate of continuous flow was well adjusted to 6ml/h and the patient achieved only one bolus in the interval.No additional information was provided.

Manufacturer Narrative

(swelling of thigh).One sampled device was returned.The pump was returned empty.A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.The pinch clamp was opened and the pump infused at all selectable flow rates.Flow accuracy testing was performed with the saf set to 8ml/hr.After 37.50 hours of testing, the pump yielded a flow rate of 7.88ml/hr which is within specifications with a +/- 20% tolerance.The pressure pot was performed on the selected-a-flow unit 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.The average bladder pressure used was 8.6psi.The saf flow rate 2ml/hr yielded a flow rate of 2.10ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.27ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.66ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 12.77ml/hr which is within specifications with a +/- 20% tolerance.Bolus button testing was performed with the pressure set to 8.6psi.The bolus was detached from the pump and the tubing was bonded back together with a male and female luer using cyclohexanone.The bolus unit was attached to the pressure gauge.The bolus button safety test results yielded an average delivery amount of 1.81g; the average is within specifications.The bolus volume test results yielded an average delivery amount of 4.28g, all results are within specifications.The investigation summary concluded that a 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.During the bolus and safety test the pca met specifications.All information reasonably known as of 13-jun-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

Event Description

Additional information received: flow rate: 6ml/h.Date of surgery: (b)(6) 2017.

• Brand Name: SURGPN,400X2-14+5,EPCMBO,-,EP,5
• Type of Device: ELASTOMERIC - COMBO
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6397007
• MDR Text Key: 69755876
• Report Number: 2026095-2017-00042
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 4440008
• Device Catalogue Number: 101353100
• Device Lot Number: 0202270796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 60