MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q* PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 400 ML; ELASTOMERIC - SAF

Model Number CB004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Swelling (2091); Tingling (2171); Numbness (2415)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

The device is reported to be available but has not yet been returned.The device history record for the reported lot number, 0202522121, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 26-sep-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 comp(b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

Event Description

Fill volume: unknown.Flow rate: 4ml/hour to 6 ml/hour.Procedure: shoulder surgery.Cathplace: neck.It was reported the patient experienced swelling of tongue, tingling and numbness around mouth.The device dial was set on 6.The patient's family member stated that the patient was concerned that his tongue felt like it was swelling.No respiratory nor swallowing difficulty was noted.The family member had clamped the tubing before calling nurse hotline.The patient denied ringing in the ears nor metal taste in mouth.The patient reported having some tingling and numbness in mouth.The family member was instructed to call the anesthesiologist immediately.The following day the family member was contacted and stated that they did reach anesthesiologist last night and were told to keep pump clamped.That morning the patient noted the swelling had decreased.Additional information received from the family member and patient on 05-sep-2017 stated the patient was well.They turned the pump off overnight and the swelling of the tongue decreased by the next day.They resumed the pump at a lower setting the following day and since then they had not had any issues.Furthermore, the family member stated that at the time of the swelling of the patient's tongue, the swollen made it hard for the patient to breathe.Additional information received from the family member and patient on 07-sep-2017 stated the patient is well.The pump was completed on (b)(6) 2017.The patient used the pump at a rate of 4 ml/hour until it was completed.The rate of the pump was at 6 ml/hour when they left hospital.While the patient was at home, the swelling of the patient's tongue occurred.It looked as if the patient was having a stroke.The patient's face looked swollen and droopy.It was around 8pm to 9pm that day when they clamped the pump.The next morning the swelling had decreased and the pump was resumed at 4 ml/hr without any further issues.No further information to be provided.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 24-oct-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).

Manufacturer Narrative

One sample device was received.The pump was received 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 rates.Flow accuracy testing was performed with the saf set to 4ml/hr.After 75-hours the pump yielded a flow rate of 3.06ml/hr which was below 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 8.61psi.The saf flow rate 2ml/hr yielded a flow rate of 1.91ml/hr, which was within specifications with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 3.79ml/hr which was within specifications with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.69ml/hr which was within specifications with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.60ml/hr which was within specifications with a +/- 20% tolerance.No crystalized medication was observed.The investigation summary concluded a fast flow was not observed.After refiling the pump to nominal volume pressure pot testing was performed and was under specification with a +/-2-% tolerance.This can be attributed to the bladder loss of elasticity after being refilled twice.Pressure pot testing was performed and each tested rate was within specification.Destructive analysis found no crystalized medication in the pump bladder.All information reasonably known as of 27-nov-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).

• 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, bc
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6895660
• MDR Text Key: 87455647
• Report Number: 2026095-2017-00177
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2019
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 0202522121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 10/02/2017; 11/16/2017
• Supplement Dates FDA Received: 10/27/2017; 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 91