MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,400X2D,PBI-AM,-,OQI,5; CATHETERS

Model Number	PS12508-A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was reported to be available but has not yet been returned.The device history record for the reported lot number, 0202415064, 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 06-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 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.
Event or Problem Description
Halyard received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is the second of two reports.Refer to 2026095-2017-00084 for the first event.Fill volume: 400; flow rate: 4ml/hr (2+2ml/hr); procedure: laparotomy for small bowel resection.Cathplace: pre-peritoneal space.A report was received from the united kingdom stating the pain buster completed earlier than expected.The infusion was expected to last around 5-days but was actually completed in 3-days.The catheter was removed uneventfully.No additional information was provided.
Additional Manufacturer Narrative
All information reasonably known as of 25-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 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).
Event or Problem Description
Additional information received 28-apr-2017 stated pain nurse practitioner provided clarification stating the initial report of the event system being completed early was initially stated (b)(6) 2017, prior to removal.
Additional Manufacturer Narrative
The pump was returned with two silver-soaker catheters.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 400ml.Infusion was verified and the flow accuracy test was performed.After 75 hours of testing, dual line #1 yielded a flow rate of 1.82ml/hr and dual line #2 yielded a flow rate of 1.82ml/hr, which is within specifications with a +/-15% tolerance.A pressure pot test was performed for this sample on the flow restrictors.The tubing was detached from the pump and connected to a pressure gauge.The average bladder pressure used was 8.16psi.The flow restrictor dual line 1 yielded a flow rate of 2.06ml/hr which is within the specification with a 15% tolerance.The flow restrictor dual line 2 yielded a flow rate of 2.06ml/hr which is within the specification with a 15% tolerance.The combined flow rate is 4.12ml/hr which is within specifications.The investigation summary concluded that a fast flow event was not observed for pump #1.During the flow accuracy test, the pump was within specifications.During pressure pot testing, the flow restrictor met specifications using the average bladder pressure.All information reasonably known as of 22-jun-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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: HYHSURGPN,400X2D,PBI-AM,-,OQI,5
• Common Device Name: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6559510
• Report Number: 2026095-2017-00085
• Device Sequence Number: 18989592
• Product Code: MEB
• UDI-Device Identifier: 30680651136238
• UDI-Public: 30680651136238
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2017

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: Nurse
• Device Expiration Date: 09/30/2018
• Device Model Number: PS12508-A
• Device Catalogue Number: 101362300
• Device Lot Number: 0202415064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 05/26/2017; 06/23/2017
• Patient Sequence Number: 1
• Patient Age: 67 YR