MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ PUMP; ELASTOMERIC INFUSION PUMP

Model Number	484011
Health Effect - Clinical Codes	Visual Impairment (2138); Chemical Exposure (2570)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Pt had a 46 hour ambulatory "smart" pump with fluorouracil infusion.Attached on (b)(6) 2019 via right chest port.Pt called in the morning on (b)(6) stating that the pump was leaking.Pt presented to office this morning with malfunction chemo"smart" pump.Huppper needle was secure and in place with sterile dressing and biopath but tubing from hummer needle to blue clave adaptor was full of blood.Connection site from clave to smart pump tubing was secured with tape but was leaking blood and 5fu chemotherapy.Pt had dried 5fu (in the form of powder) on her abdomen and fanny pack.All clamps were open.Clamps were then closed and pump disconnected from blue clave adaptor.It was then noted that the male adaptor from the smartpump tubing was broken off inside the clave adaptor.Port access was removed without flushing and all lines and pump were secured in biohazard bag.Pt's skin and surrounding area was washed with ns and gauze.Port was re-accessed under sterile technique, flushed without resistance and has a good blood return.Md notified of incident.Pt is refusing a new pump at this time.Pt reported side effects of blurred vision starting yesterday evening - to the pint that she was afraid she was going blind.Pt states that her vision is better this morning - but does not want the pump again today.Md noticed of all pts concerns and of the pt's refusal to receive remain medication.No new orders received.
Additional Manufacturer Narrative
Device history record for this lot did not show any issue related to broken luer lock.Retained samples were also subjected to luer lock functional test and no leakage was found.

• Brand Name: SMARTEZ PUMP
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard; industrial estate 500/73; moo 2, tasit pluak daeng, rayong 21140 ; TH 21140
• MDR Report Key: 9801643
• Report Number: 3012429465-2020-00005
• Device Sequence Number: 11282238
• Product Code: MEB
• UDI-Device Identifier: 18859299104017
• UDI-Public: (01)18859299104017(10)C8M04(17)211028(11)181128(241)SE0002-100C
• Combination Product (Y/N): N
• PMA/510(K) Number: K151650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 484011
• Device Lot Number: C8M04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1