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

Model Number	CB6004
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not 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 27-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.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).Device not returned.
Event or Problem Description
Fill volume: 500 ml, flow rate: 6 ml/hr, procedure: hysterectomy, cathplace: under umbilicus, infusion start time: 1136 on (b)(6) 2018, infusion stop time: unknown.It was reported that a patient initially called to inquire on how to tell if the elastomeric pump was empty.The patient stated that the pain was minimal, and nonexistent at the time of the report.The pump was set to a rate of 6 ml/hr since the surgery and was advised not to change the rate.The dressing at the insertion site, below the belly button, was dry and intact.The catheter was also intact with no kinks.The patient stated she could not recall what the pump looked like originally, but noted that it was smaller in size comparable to a tangerine.Then the patient noted that the pump was empty.The patient removed the catheter without any difficulty and with no site redness, swelling, or drainage.Additional information received on (b)(6) 2018 from the patient stated that she was currently in stable condition.The pain was minimal with not signs of any drug toxicity.She awoke on saturday morning, (b)(6) 2018 and felt that the pump was lighter.She did not check until noon when she realized it was empty.The pump was carried in an on-q bag on her shoulder like a purse, and placed in her lap when she sat.When she slept, she slept on her side and the pump was place on the bed in front of her stomach.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 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.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).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.
Additional Manufacturer Narrative
The sample pump was received empty and used.The pump was evaluated and it was concluded that fast flow was not observed.During the flow accuracy test, the pump was within specification.During pressure pot testing, the select-a-flow (saf) was within specifications as well.Based on the information provided, pump was filled with 500 ml instead of 600 ml which is the labeled fill volume for cb6004.According with the instructions for use, under filling the pump can lead to a fast flow condition; therefore, potential root cause is an incorrect use.All information reasonably known as of (b)(6) 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.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).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.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 600 ML, 2-14 ML/HR
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7645737
• Report Number: 2026095-2018-00072
• Device Sequence Number: 16522076
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/22/2020
• Device Model Number: CB6004
• Device Catalogue Number: 101347603
• Device Lot Number: 0202925856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 09/19/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/03/2018; 10/12/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2 NAROPIN
• Patient Age: 40 YR
• Patient Weight: 93