MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB004

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

Patient Problems Diarrhea (1811); Lethargy (2560); No Code Available (3191)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The sample is reported to be available but has not yet been returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 09-may-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 (b)(4) 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 (b)(4).(b)(4) 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 (b)(4) complaint database and identified as complaint (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 (b)(4) product is defective or caused serious injury.

Event Description

Fill volume: 550 ml; flow rate: 8 ml/hr; procedure: total knee, left; cathplace: thigh.It was reported that a patient had a metallic taste associated with the use of an elastomeric homepump that started a few hours prior to this report.It occurred only when the patient would take a drink of water.The patient clamped the pump 10 minutes ago and the taste was beginning to dissipate.The patient was advised to call the anesthesiologist to make him aware of the side effect, especially since there was little medication that remained in the pump.Additional information received on 21-apr-2017 from the patient stated that she was feeling a lot better since the pump was clamped and catheter removed.For the last three days, she was feeling lethargic and had bouts of diarrhea.Since discontinuation, she reported that she no longer feels lethargic and is more awake.She is no longer experiencing the metallic taste in her mouth, and the diarrhea has subsided.The patient had surgery on (b)(6) 2017, and the pump's infusion started at 7:00 am that day.She was discharged the next day, and the pump continued infusion without incident.It provided full pain relief until 2:00 am on the night of (b)(6) 2017.She reported to take a sip of water and experienced the metallic taste.She immediately clamped the pump and called the nurse hotline.After the call, she removed the catheter and discontinued the pump's infusion in its entirety.The pump still had medication left, and the patient noted it had approximately 10-12 hours remaining.Two hours after she experienced the metallic taste, she took another sip of water at 4:00 am, and there was not metallic taste again.There were no warming devices used.The pump was located in the pouch under the patient's blankets that night, next to her waist.No further information was provided.

• Brand Name: HYHSURGPN,400X2-14,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, bc 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6559509
• MDR Text Key: 74891388
• Report Number: 2026095-2017-00083
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/21/2017

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: 07/02/2019
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 0202601218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 0.2% ROPIVACAINE
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 52