MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP C-SERIES, 100 ML, 2 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number C100020

Device Problem Infusion or Flow Problem (2964)

Patient Problems Dehydration (1807); Erythema (1840); No Code Available (3191)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

Burning sensation in testicles.The actual device was reported to be available but was not returned.The device history record for the reported lot number, 0202766233, 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 29-nov-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).The device was not returned.

Event Description

Fill volume: 125 ml; flow rate: 2 ml/hr; procedure: unknown ; cathplace: port.The patient's pump was attached and was infusing 5fu.The pump was set to infuse for 46-hours.The patient was at home when he thought his pump was infusing a little faster than usual.Therefore, the patient went to the clinic to get the pump assessed on thursday ((b)(6) 2017).The nurse, checked the pump and the device line and everything was fine.There were no kinks or crimps to the line, and the clamp was open.In fact, the nurse indicated that the pump still looked very full after 2-days of infusing.The patient instructed the patient to go home.However, the pump completely infused before the patient returned home.The patient lived one and a half hour away from the infusion clinic.The patient experienced signs and symptoms of red flushed feeling.There was no other further incident.The patient made his way back to the clinic the following day ((b)(6) 2017).The patient exhibited signs and symptoms of a red beet flushed face, testicles felt like they were burning, and dehydration.The doctor stated that the signs and symptoms were caused by the fast flow infusion of the chemotherapeutic medication.Patient was administered fluids as a results of the signs and symptoms exhibited after the fast flow of 5fu.When these symptoms occurred on thursday night, the patient took a cold shower and rinsed his body with hebi-cleanse.It was reported the patient was currently in stable condition.The nurse did not know if the patient had used any warming devices or had any heat around him during the infusion, if the patient had applied any pressure to the pump, or where the pump was located during the infusion.He was driving when the fast infusion occurred.The pump was hooked to his port.No further information to be provided.

Manufacturer Narrative

One sample device was received.The pump was received empty.A visual observation found drug crystallization in the tubing just below the filter outlet port.A baxa repeater pump was used to refill the pump with 0.9% saline.After opening the pinch clamp no infusion was observed.A syringe was connected to the distal luer and negative suction applied for a few minutes after which infusion was observed.Flow accuracy testing was performed on the pump.The pump was allowed to infuse for 37.5 hours and had a flow rate of 1.87ml/hr which is within specification with a +/-15% tolerance.Pressure pot testing was performed on the glass orifice.The tubing was detached from the pump and hooked onto a pressure gauge and the filter was removed from the tubing.The average bladder pressure used was 9.63psi.After 5 hours the glass orifice yielded a flow rate of 1.92ml/hr, which is within specification with a +/- 20% tolerance.The investigation summary concluded that a fast flow was not observed.Drug crystallization was observed in the empty pump when it was received.After refilling the pump to nominal volume, it did not infuse until after negative suction was applied.Flow accuracy testing was performed and was within specification.Pressure pot testing without the filter and all tested rates met specification with a +/- 20 tolerance.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: HOMEPUMP C-SERIES, 100 ML, 2 ML/HR (CONTAINS DEHP)
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7076687
• MDR Text Key: 94860125
• Report Number: 2026095-2017-00200
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651135613
• UDI-Public: 30680651135613
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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
• Device Operator: Nurse
• Device Expiration Date: 01/09/2020
• Device Model Number: C100020
• Device Catalogue Number: 101356105
• Device Lot Number: 0202766233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/20/2018
• Patient Sequence Number: 1
• Treatment: 5FU; HEBI-CLEANSE
• Patient Age: 63 YR
• Patient Weight: 145