MAUDE Adverse Event Report: HALYARD - IRVINE HYHSURGPN,270X5,HMPMPC,-,LFR-CS,24; ELASTOMERIC

Model Number C270050

Device Problem Infusion or Flow Problem (2964)

Patient Problems Diarrhea (1811); Fatigue (1849); Nausea (1970); Abdominal Cramps (2543)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record for the lot number, 0202495523, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 03 apr 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)(4) 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)(4).(b)(4) 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 (b)(4) 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 (b)(4) product is defective or caused serious injury.

Event Description

(b)(4) received a single report that referenced 2 different incidences, which were associated with separate units, involving the two different patients.This is the second of two reports.Refer to 2026095-2017-00050 for the first patient.Fill volume: 241 ml; flow rate: 5 ml/hr; procedure: unknown; cathplace: unknown.A report was received from (b)(6) stating there were two fast flow events.For the second event the pump was set to deliver the drug in 46-hours.Patient went to the oncology center and reported the infusion ended at 7:00 a.M.Instead of 3:00 p.M.The infusion ended 8- hours ahead of schedule.The patient reported experiencing fatigue, nausea and denies abdominal cramps or diarrhea.No further information to be provided.

Manufacturer Narrative

Correction: sex-no information, patient code(s)- patient denied abdominal cramps and diarrhea which was reported on the initial report.All information reasonably known as of 25-apr-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).

• Brand Name: HYHSURGPN,270X5,HMPMPC,-,LFR-CS,24
• Type of Device: ELASTOMERIC
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6461789
• MDR Text Key: 72178063
• Report Number: 2026095-2017-00051
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651135682
• UDI-Public: 30680651135682
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

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
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/24/2019
• Device Model Number: C270050
• Device Catalogue Number: 101356804
• Device Lot Number: 0202495523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1