MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,100X100,HM PMP,-,EC,48; ELASTOMERIC HFR

Model Number E101000

Device Problem Human Factors Issue (2948)

Patient Problems Death (1802); Dysphagia/ Odynophagia (1815); Pain (1994); Fungal Infection (2419)

Event Date 02/16/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The 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.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 Description

It was reported by the patient's sister-in-law that the patient died on (b)(6) 2016.The sister-in-law found three pumps in the trash can of the hospital room.There was no reported product malfunction associated with any of the pumps.Additional information received on 27-sep-2016, the family member reported that the patient was on palliative care and was being treated for brain cancer.The patient was admitted to the hospital for treatment for oral shingles.On the day of the patient's death, the patient's family found pumps in the garbage.One was empty, one was partially full, and another was never given to the patient.The family cut the tubing of one to see if there was medication still in the pump, and it squirted all over the room until it emptied.The pump was filled with 400mg acyclovir.Additional information received from the family member reported that the patient was admitted on (b)(6) 2016 for treatment of what they originally started off as thrush.The patient passed after not getting treated with the right medication.When the patient was diagnosed and started received the correct medication, the family stated the patient was not given the correct dose.The family found the full medication ball in the trash on the date of the patient's death.Per the family member's report, on or about (b)(6) 2016, the patient began to display symptoms of oral pain and could not eat or drink for a few days.She was first treated for oral thrush with nystatin and diflucan, but the symptoms were worsening.On (b)(6) 2016, she was transferred to a different unit and diagnosed with oral shingles.The three pumps that the patient's family saved were kept in the freezer by the family.A family member was not sure if the husband wanted to the send the pumps for testing immediately.The reporter noted that there was no product malfunction or issues with the pumps, but wanted to know how much medication remained in the pump.Additional information received on 30-sep-2016 from a hospital staff member stated that 3 pumps for acyclovir therapy for (b)(6) 2016 were found in the trash can in the patient's room on (b)(6) 2016.The patient was on acyclovir 3 times a day since she was first admitted.It was noted that the medication from the 3 pumps might not have infused correctly.The reporter thought that the infusion might have slowed down due the slowing circulation since the patient was passing.At the time, the doctor stated that the patient's infection was resolving after 8 days of treatment.No further information available.

• Brand Name: SURGPN,100X100,HM PMP,-,EC,48
• Type of Device: ELASTOMERIC HFR
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6041480
• MDR Text Key: 57875407
• Report Number: 2026095-2016-00169
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: E101000
• Device Catalogue Number: 101354900
• Device Lot Number: 0202292261
• Other Device ID Number: 10680651135497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 400MG ACYCLOVIR; DIFLUCAN; NYSTATIN
• Patient Outcome(s): Death
• Patient Age: 40 YR