MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,CB006,CBCMBO,-,OQ,5; ELASTOMERIC - COMBO

Model Number CB006

Device Problems Sticking (1597); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record for the lot number, 0202315885, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was returned.The pump was returned partially full.A visual observation found the tip of the red prime key was broken off and remained.The pinch clamp was opened and infusion was verified when setting the saf to all the flow rates.The tubing was cut 2 inches distal to the blue connector to drain the medication.The pump was bonded back together with a male and female luer.The pump was refilled to nominal volume with 0.9% of saline using a baxa repeater pump.The flow accuracy test was performed with the saf set to 8ml/hr.After 37.5 hours of testing, the pump yielded a flow rate of 12.04ml/hr which is above specification with a +/- 20% tolerance.Pressure pot testing 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 7.94psi.The saf flow rate 2ml/hr yielded a flow rate of 2.09ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.13ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.55ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 12.92ml/hr which is within specifications with a +/- 20% tolerance.Destructive analysis was performed on the pca.The housing was opened and the red piece was examined under magnification and found signs of stress on the plastic.The investigation evaluation summary concluded that fast flow was observed.The tip of the red prime key was found to be broken off and remaining in the pca keeping the bypass tubing open.During the flow accuracy test, the pump was above specifications with the saf set to 8ml/hr.During pressure pot testing, all flow rates met specifications using the average bladder pressure.Destructive analysis found stress on the red piece when it was examined under magnification.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: 550 ml.Flow rate: unknown.Procedure: right ankle arthroplasty.Cathplace: saphenous and sciatic.A report was received stating the pca bolus device would not lock down.The pump was connected to the patient and when the bolus button was pressed down to engage the device, the bolus button would not lock down.The typical process for this hospital is to connect the pump to the patient and educate the patient on how to use the device.The nurse stays in the room with the patient to ensure that the device is functioning and that the patient knows how to use the device.In this case, it was immediately noticed that the device did not functioning.There was no report of patient injury.No further information to be provided.

• Brand Name: SURGPN,CB006,CBCMBO,-,OQ,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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5913602
• MDR Text Key: 54280335
• Report Number: 2026095-2016-00126
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2016

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 Expiration Date: 11/30/2017
• Device Model Number: CB006
• Device Catalogue Number: 101347400
• Device Lot Number: 0202315885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• 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