MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,600X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB6004

Device Problem Infusion or Flow Problem (2964)

Patient Problems Tinnitus (2103); Anxiety (2328)

Event Date 04/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.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.The device history record for the lot number, 0202308497, 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.(b)(4).

Event Description

Halyard received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the first of two reports.Refer to 2026095-2016-00041 for the second incident.Fill volume: 750 ml, set flow rate: 6ml/hr, procedure: pilon fracture surgery, cathplace: unknown, infusion started: (b)(6) 2016, infusion ended: (b)(6) 2016.A report was received from the patient stating ringing in the ear was experienced while using the on-q pumps.The patient underwent surgery on (b)(6) 2016.The patient had two saf pumps infusing at 6ml/hr each.The on-q pumps were inserted at the hospital and the patient was discharged to home.The patient independently turned the pumps off and within 7-minutes the tinnitus resolved.The patient was instructed to contact the physician to determine additional intervention(s).The physician never returned the patient's telephone call.The symptoms had resolved.It was reported the pumps were used under room temperature at the patient's home.Additional information from the patient received 14-apr-2016 stated ".Though, i did end up speaking to a doctor, and we concluded that what i was experiencing was just severe anxiety.I don't think the pumps had anything to do with it anymore.I'm sorry i didn't let you know sooner." no additional was provided.

Manufacturer Narrative

One sample device was returned.The original packaging was not returned with the device.The pump was returned full.The pinch clamp was opened and the pump infused at all selectable flow rate.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.A baxa repeater pump was used to refill the pump with 600ml.Flow accuracy testing was performed with the saf set to 6ml/hr.After 75 hours of testing, the pump yielded a flow rate of 4.72ml/hr which is below specifications 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 7.1psi.The saf flow rate 2ml/hr yielded a flow rate of 2.08ml/hr, which is within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.02ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.96ml/hr which is within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 14.00ml/hr which is within specifications with a +/- 20% tolerance.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,600X2-14,CB SAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• 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: 5609461
• MDR Text Key: 44475209
• Report Number: 2026095-2016-00040
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: CB6004
• Device Catalogue Number: 101347602
• Device Lot Number: 0202308497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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
• Patient Outcome(s): Other