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

Model Number CB006

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The device history record for the lot number, 0202357110, 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.(b)(4).

Event Description

Fill volume: 550 ml, flow rate: unknown, procedure: knee replacement, cathplace: femoral nerve block.A report was received stating an on-q pain device was prefilled and when the device was hooked up to the patient the button component would not stay down when pressed, it popped right back up.Additional information received on 29-jun-2016 stating the pump was connected to the patient and the nurse attempted to delivered the first dose to the patient, she pushed the button but it would not latch.The yellow indicator was noted on the bottom.The nurse disconnected this pump from the patient and replaced it with another pump.When the pump was returned to the pharmacy, the complainant attempted another push.The button would not latch.The yellow indicator was noted on the bottom.There was no adverse event related to this incident.

Manufacturer Narrative

The sample was received partially full and infused at all selectable flow rates when the pinch clamp was opened.A visual observation found the tip of the red prime key had broken off and remained in the pca keeping the by-pass valve open.The tubing was cut two inches below the blue connector to drain the pump.A baxa repeater pump was used to refill the pump with 400ml of 0.9% saline.The flow accuracy test was performed with the (select-a-flow) saf set to 6ml/hr.After 38.67 hours of testing, the pump yielded a flow rate of 11.66ml/hr which is above the maximum 11.66ml/hr per specifications with a +/- 20% tolerance.Pressure pot testing was performed on the flow control tubing (selected-a-flow unit) flow rates 2ml/hr, 4ml/hr, 8ml/hr and 14ml/hr.The saf unit was detached from the pump and hooked onto a pressure gauge.The average bladder pressure used was 7.81psi.Flow rate 2ml/hr yielded a flow rate of 1.92ml/hr, which is within specification with a +/- 20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.50ml/hr, which is within specification with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.49ml/hr, which is within specification with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.09ml/hr, which is within specification with a +/- 20% tolerance.The evaluation summary concludes that a fast flow was observed.The pump infused at all selectable rates when it was received.A visual observation found the tip of the red prime key had broken off and remained in the pca keeping the by-pass valve open.During flow accuracy testing the pump had a rate that was above specification with a +/-20% tolerance.During pressure pot testing for the flow control tubing (saf unit) without the pump, the flow rates met specifications using the average bladder pressure.The complainant reported ¿stuck up / not latching" for one pump.Root cause is attributed to the tip of the red prime key that was broken off and remained in the pca keeping the by-pass valve open.According to ongoing investigations, improper removal of the prime key, by the user, is the cause of this failure.This failure will prevent the lever arm from being released to pinch the by-pass tubing, which begins the refilling of the reservoir.Investigations are currently ongoing in order to mitigate future incidents.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.(b)(4).

• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5815354
• MDR Text Key: 51020170
• Report Number: 2026095-2016-00098
• 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: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/10/2016

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: 01/31/2018
• Device Model Number: CB006
• Device Catalogue Number: 101347404
• Device Lot Number: 0202357110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 92