MAUDE Adverse Event Report: HALYARD - IRVINE ON-QPUMP SOAKER 5IN(12.5CM): 270ML, DUAL 2+2ML/HR; ELASTOMERIC PUMP

Model Number PM025

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

Patient Problems Tinnitus (2103); Reaction (2414)

Event Date 04/17/2015

Event Type  Injury  

Event Description

Fill volume: 300ml.Flow rate: 4ml/hr (2ml +2ml).Procedure: double umbilical hernia repair ((b)(6) 2015).Cathplace: umbilical hernia region.It was reported that a patient experienced a metallic taste in mouth at the end of a pump's infusion.The infusion began the same day that the patient had surgery.The infusion was expected to infuse for 3.5 days.The infusion ended on (b)(6) 2015 and the pump appeared empty at the end of the infusion.Upon waking in the morning of (b)(6) 2015, the patient experienced a metallic taste in her mouth.The pump and catheter were removed later that day as the patient had been instructed to wait until post-op day 4 to remove the device.Upon removing the catheters, the patient began to experience ringing in the ears.The patient was advised to contact the surgeon.No medical intervention was reported.The device is available for return.Additional information was received on (b)(4) 2015.The patient reported that she was doing fine and symptom of metallic taste had resolved.

Manufacturer Narrative

(b)(4).No known device problem.Method: the device was received for analysis.A visual inspection and a review of the device history record (dhr) were performed.Results: there are no testing results available as the investigation and evaluation are currently in progress.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the analysis and investigation are completed, a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Manufacturer Narrative

Methods: along with the previously reported methods, a flow rate accuracy test and pressure pot testing were conducted.Results: the pump was received empty and then was refilled to the nominal fill volume and infusion was immediately observed.A flow accuracy test was performed.After 50.75 hours of testing, dual line #1 yielded a flow rate that was within specifications with a 15% tolerance.Dual line #2 yielded a flow rate that was within specifications with a 15% tolerance.The combined flow rate was within specifications.Pressure pot testing was performed for the sample on the flow restrictors.The tubing was detached from the pump and connected to a pressure gauge.The flow restrictor dual line #1 yielded a flow rate that was within the specification with a 15% tolerance.The flow restrictor dual line #2 yielded a flow rate that was within the specification with a 15% tolerance.The combined flow rate was within specifications.Conclusions: the investigation summary concluded that infusion was observed.During the flow accuracy test, the pump was within specifications.Pressure pot testing was performed and the flow restrictors met specifications with a 15% tolerance.As previously reported, the lot met the process specifications, including the quality control acceptance criteria prior to release.Based on this investigation the complaint disposition is not confirmed.The assignable cause of this incident is unknown.It was reported that the patient experienced metallic taste in mouth following use of the pump and that the patient was taking supplemental tylenol #3 at the time of the event.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.Since user conditions were not reported, it cannot be determined if the user condition may have contributed to the reported incident.The ifu specifies the following: "medications or fluids must be administered per instructions provided by the drug manufacturer.Physician is responsible for prescribing drug based on each patient¿s clinical status (such as age, body weight, disease state of patient, concomitant medications, etc.).It is the responsibility of the healthcare provider to modify patient guidelines provided with the pump as appropriate for your patients¿ clinical status and medication prescribed." an historical review indicated that no other complaints were reported for this reported incident and related to the same lot number.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-QPUMP SOAKER 5IN(12.5CM): 270ML, DUAL 2+2ML/HR
• Type of Device: ELASTOMERIC PUMP
• 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 b.c. 2211 6
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4766722
• MDR Text Key: 16179564
• Report Number: 2026095-2015-00147
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: PM025
• Device Catalogue Number: 101364000
• Device Lot Number: 0202037092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MARCAINE 0.5%; CLINDAMYCIN 300MG; TYLENOL 3
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 73