MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; REGIONAL ANESTHESIA PUMP KITS

Model Number CB004

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Reaction (2414)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint product is reported to be available, but has not yet been received by the manufacturer.The device history record for the lot number, 0300050312, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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 (b)(4).Device not returned.

Event Description

Fill volume: 500 ml, flow rate: 4, 8, 4 ml/hr, procedure: rotator cuff repair, right, cathplace: unknown.Rate was set at 4ml/hr since surgery.9-10pm on (b)(6) turned up to 8; 10pm down to 4.It was reported that a male patient's pump was set at a rate of 4ml/hr since the surgery.On (b)(6) 2016 at 9-10 pm, the rate was turned up to 8 ml/hr, and turned back down to 4 ml/hr at 10 pm.On (b)(6) 2016 the patient reported having ringing in the ears during use of the pump.The patient woke up at 2:30 am on (b)(6) 2016 with ringing in the ears.The patient was instructed to turn off the pump at 3:00 am by the hotline nurse.The patient woke up at 6:00 am and the ringing was gone.The anesthesiologist called the patient back at 7:30 am to instruct the patient to turn the pump on again and to set at 4 ml/hr.At 12:30 pm the patient felt ringing in the ears again.The anesthesiologist told the patient to resume infusion once the ringing goes away.No additional information was provided.

Manufacturer Narrative

The pump was returned partially full.The pinch clamp was opened and the pump infused at all selectable flow rates.The tubing was cut below the blue connector to drain the medication.A male and female luer were used with cyclohexanone to bond the tubing back together.The pump was refilled to nominal volume with 400ml of 0.9% saline using a baxa repeater pump.Flow accuracy testing was performed with the saf (select-a-flow) set to 14ml/hr.After 21.5 hours of testing, the pump yielded a flow rate of 2.53ml/hr which is within specifications with a +/- 20% tolerance.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 8.16psi.No infusion was seen at the distal luer.The filter was removed and then infusion was found at all selectable rates.The saf flow rate 2ml/hr yielded a flow rate of 1.71ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.98ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.13ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 12.95ml/hr which is within specifications with a +/- 20% tolerance.The evaluation summary concluded that a fast flow was not observed.During the flow accuracy test, the pump had a flow rate that was below specification with a +/-20% tolerance.During pressure pot testing the saf would not initially infuse at any rate.After removing the filter flow was observed at each rate and the pressure pot testing met specifications at each of the selected rates when using the average bladder pressure.It was not able to be determined why the filter was preventing flow.The pump had a flow rate that was below specification with a +/-20% tolerance.During pressure pot testing the saf would not initially infuse at any rate.After removing the filter flow was observed at each rate and the pressure pot testing met specifications at each of the selected rates when using the average bladder pressure.It was not able to be determined why the filter was preventing flow.Root cause could not be determined.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).

• Brand Name: SURGPN,400X2-14,CB SAF,-,OQ,5
• Type of Device: REGIONAL ANESTHESIA PUMP KITS
• 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: 6150627
• MDR Text Key: 62127370
• Report Number: 2026095-2016-00218
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

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: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: 0300050312
• Other Device ID Number: 30680651134722
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE 0.2% 500ML
• Patient Age: 67 YR
• Patient Weight: 91