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

Model Number C270050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Pyrosis/Heartburn (1883); Nausea (1970); Pain (1994); Vomiting (2144); Ulcer (2274); No Code Available (3191)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual 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.Root cause could not be determined.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).Device not returned.

Event Description

Fill volume: 249 ml, flow rate: 5 ml/hr, procedure: chemotherapy, date of procedure: (b)(6) 2016, infusion start time: (b)(6) 2016, unknown time, finished (b)(6) 2016, 21:00, cathplace: n/a.It was reported that a patient's elastomeric infusion pump was supposed to infuse for 48-hours, but infused within 32-hours.The patient became ill after the infusion, experiencing nausea, vomiting, aches, ulcers, heartburn, and skin blistering since (b)(6) 2016.It was noted that the symptoms resolved themselves over time.No additional information was provided.

• Brand Name: SURGPN,270X5,HMPMPC,-,LFR-CS,24
• Type of Device: ELASTOMERIC LFR
• 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: 6301851
• MDR Text Key: 66555933
• Report Number: 2026095-2017-00012
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: C270050
• Device Catalogue Number: 101356802
• Device Lot Number: 0202409604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5FU/NACL
• Patient Outcome(s): Other