MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - SAF

Model Number	CBI6007
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was reported to be available but has not yet been returned.A review of the device history record is in-progress.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.(b)(4).
Event or Problem Description
Fill volume: 600 ml, flow rate: 2 x 7 ml/hour (hr), cathplace: abdomen, date/time infusion start time: (b)(6) 2017 13:15, date/time infusion stop time: (b)(6) 2017 21:10.It was reported that the pump delivered quicker than expected.The pump had 600 mls in volume and there was 172 mls discrepancy in a 32-hour period.The rate was set at 2 x 7 mls/hr ( dual pump).Additional information received 10-oct-2017 stated the dual pump device over administered 72 mls over a 32-hour period.No additional information was provided.
Additional Manufacturer Narrative
Additional information: actual device returned, evaluation in process.The device history record for the reported lot number, 0202720155, 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 07-dec-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)(6) 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)(6).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
A dual line saf pump was received empty.A baxa repeater pump was used to refill the pump with 600ml of 0.9% saline.The pinch clamp was opened and the pump infused at all selectable rates on both saf¿s.Flow accuracy testing was performed with the saf¿s set to 7ml/hr.After 32.5 hours line #1 yielded a flow rate of 6.07ml/hr and line #2 of 6.15ml/hr, both rate are within 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 7.54psi.The saf flow rate 1.12ml/hr yielded a flow rate for line #1 of 1ml/hr and 1.13ml/hr for line #2, which is within specifications with a +/-20% tolerance.Flow rate 2ml/hr yielded a flow rate for line #1 of 2.05ml/hr and 1.99ml/hr for line #2, which is within specifications with a +/- 20% tolerance.Flow rate 4ml/hr yielded a flow rate of 4.38ml/hr for line #1 and 4.04ml/hr for line #2 which is below specifications with a +/- 20% tolerance.Flow rate 7ml/hr yielded a flow rate of 7.70ml/hr for line #1 and 7.36ml/hr for line #2, which is below specifications with a +/- 20% tolerance.Destructive analysis was performed using a dremel to cut open the bladder.No crystalized medication was found.The investigation summary concluded that a fast flow was not observed.Flow accuracy testing was performed and the pump met specification with a +/-20% tolerance.Pressure pot testing was performed.All the tested rates for each saf met specification with a +/-20% tolerance when using the average bladder pressure.Destructive analysis found no crystalized medication in the bladder.All information reasonably known as of 29-jan-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).

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6974771
• Report Number: 2026095-2017-00183
• Device Sequence Number: 497746
• Product Code: MEB
• UDI-Device Identifier: 30680651134852
• UDI-Public: 30680651134852
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2018

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: Other Health Care Professional
• Device Expiration Date: 12/26/2019
• Device Model Number: CBI6007
• Device Catalogue Number: 101348500
• Device Lot Number: 0202720155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 11/20/2017; 01/09/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 12/07/2017; 02/01/2018
• Patient Sequence Number: 1