MAUDE Adverse Event Report: HALYARD HEALTH - IRVINE ON-Q* PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 600 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB6004

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record for the reported lot number, 0202858989, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The product involved in the report has been returned and is being processed for evaluation.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 14apr2018 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.(b)(4).

Event Description

Fill volume: 750 ml, flow rate: 8 ml/hr, procedure: total knee replacement, cathplace: unknown.It was reported that a patient experienced a "funny taste" or metallic taste in their mouth while using the device.The nurse clamped off the pump and anesthesia was called and the anesthesiologist removed the patient from the pump.There was also reported leaking around the insertion site prior to removal of the device.The patient was reported to be feeling much better.No additional information was provided.

Manufacturer Narrative

One sample device was received partially full.After opening the pinch clamp, an infusion was observed at all selectable rates.The tubing was cut below the blue connector to drain the pump.A male and female luer were used with cyclohexanone to bond the tubing back together.A baxa repeater was used to refill the pump with 600ml of 0.9% saline.Flow accuracy testing was performed with the select-a-flow (saf) set to 8ml/hr.The pump was allowed to infuse for 56.25 hours and had a flow rate of 6.39ml/hr which was slightly below specification with a +/-20% tolerance.Pressure pot testing was performed on the flow control tubing, saf, unit flow rates 2, 4, 8 and 14ml/hr.The saf unit was detached from the pump and hooked onto a pressure gauge and the filter was removed from the tubing.The average bladder pressure used was 6.99psi.Flow rate 2ml/hr yielded a rate of 2.16ml/hr which was within specification with a +/-20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.08ml/hr, which was within specification with a +/- 20% tolerance.Flow rate 8ml/hr yielded a flow rate of 7.79ml/hr, which was within specification with a +/- 20% tolerance.Flow rate 14ml/hr yielded a flow rate of 13.90ml/hr, which was within specification with a +/- 20% tolerance.Destructive analysis was performed on the patient care analgesia (pca).The housing was opened and no damage was observed to the internal components.A syringe with saline and food grade dye were connected to the bolus inlet tubing and the bolus refill with the mixture.The bolus was then depressed and the contents expelled out of the pca outlet tubing.No occlusion was evident.The investigation summary concluded that a fast flow was not observed.The pump infused at all selectable rates when it was received.Flow accuracy testing was performed with the saf set to 8ml/hr and the pump filled to nominal volume.The flow rate was below specification but may be attributed to being filled more than once.Pressure pot on the saf flow rate was performed and all of the rates met specification with a +/-20.No crystalized medication was observed in the bladder after cutting it open.Root cause could not be determined.All information reasonably known as of 19-jun-2018 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.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 HEALTH - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7439667
• MDR Text Key: 106598138
• Report Number: 2026095-2018-00046
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

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: 05/14/2020
• Device Model Number: CB6004
• Device Catalogue Number: 101347600
• Device Lot Number: 0202858989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/20/2018
• Patient Sequence Number: 1
• Treatment: 0.2% ROPIVACAINE
• Patient Age: 52 YR
• Patient Weight: 100