MAUDE Adverse Event Report: HALYARD - IRVINE HALYARD HOMEPUMP ECLIPSE AMBULATORY INFUSION SYSTEMS; NON-DEHP PUMP - HFR

Model Number	E100500
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is reported to be available but has not yet been returned for evaluation.The device history record for the reported lot number, 0202687458, 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 04-jun-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).
Event or Problem Description
Fill volume: unknown.Flow rate: unknown.Procedure: ear infection.Cath.Place: central.Infusion start time: (b)(6) 2018 10:00 pm.Infusion stop time: (b)(6) 2018 12:00 am.It was reported that a (b)(6) child experienced their head turning red while using an elastomeric homepump filled with vancomycin 132mg.It was noted that the pump was running too fast.The pump was empty upon disconnection.Further information noted that the pump ran over the course of one hour.The order was changed for the pump to run two hours for the patient the previous day.The patient experienced her head turning red the next day.During the call to report this issue, the patient¿s head was no longer red.The order was for the patient to receive infusion of vancomycin 132mg over two hours.The rate was unknown.The patient¿s condition after the event was reported to be stable.Additional information received on 22-may-2018 stated that this event was a fast flow issue.The pump used on the baby was ordered for two hours, and it only ran for over an hour.The baby experienced red head syndrome, but the reaction dissipated.Additional information received on 30-may-2018 stated that the ball infused with vancomycin was supposed to last for one hour for her daughter, but it only lasted for 40 mins.The baby girl developed "red man syndrome" and the symptoms subsided shortly after.The baby was admitted to the hospital for an overnight stay and she was released home afterward.The baby is still on vancomycin treatment with the balls but experiences no further issues.

• Brand Name: HALYARD HOMEPUMP ECLIPSE AMBULATORY INFUSION SYSTEMS
• Common Device Name: NON-DEHP PUMP - HFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7575630
• Report Number: 2026095-2018-00062
• Device Sequence Number: 10831802
• Product Code: MEB
• UDI-Device Identifier: 30680651135484
• UDI-Public: 30680651135484
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 05/13/2018

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
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 10/05/2019
• Device Model Number: E100500
• Device Catalogue Number: 101354803
• Device Lot Number: 0202687458
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2018
• Initial Report FDA Received Date: 06/06/2018
• Patient Sequence Number: 1
• Patient Age: 1 YR