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

Model Number 484041

Device Problems Improper Flow or Infusion (2954); Pumping Problem (3016)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Syncope/Fainting (4411)

Event Date 01/13/2023

Event Type  Death  

Manufacturer Narrative

Manufacturer: epic international thailand co., ltd.Product: smartez elastomeric pump; model#: 484041; lot#: c22e043.Adverse event reported: a 64-year-old male was presented to emergency department with complaints of chest abdominal pain status post syncopal episode & expired.On february 1, 2023, we received a medwatch (mw5114504) report of an adverse event reported by user facility who had used our smartez elastomeric pump.As per the description of the report, 64-year-old male patient (identifier: (b)(6), weight:62kg) was presented to cancer centre for continuous infusion of 5fu (fluorouracil) by elastomeric pump.Patient returned for disconnect & reported that infusion completed in 5hrs.Patient was presented to emergency department with complaints of chest abdominal pain status post syncopal episode & expired.Patient had been on folfiri since (b)(6) 2022.Last dose was placed on continuous infusion on (b)(6) 2023 at approximately 8:30am.It was a 46-hour infusion and patient returned for disconnect on (b)(6) 2023.Pump was disconnected at approximately 12:30pm.Patient died on (b)(6) 2023.The patient had pre-existing conditions of liver mass with liver resection, metastatic ca - liver and lung, +smoker, colostomy, neuropathy, gerd as per the information provided by (b)(6) hospital, contact (b)(6), health professional.The laboratory test data indicates wbc 2.1, bun 65, bilirubin 1.6, alp - 251, pt 16, hgb 13.7, hct - 40 & the diagnosis report shows multisystem organ & respiratory failure.We immediately requested for the photo of the device & supposedly defect sample to return for investigation.Photo of the device has been received.We reviewed the dhr & testing records for lot# c22e043, catalog# se0005-270c, model#: 484041 associated with the adverse event, found no issues or deviations from standard operating procedures and specifications.We also did a retrospective review of the complaints & found no other report of adverse event associated with this lot and there were no complaints attributed to such adverse event outcome.Since the defect device has not been returned yet by (b)(6), a detailed investigation is not possible.We will also provide updates as additional information becomes available.

Event Description

Pt presented to cancer center for continuous infusion of 5 fu by elastomeric pump on (b)(6) 2023.Returned for disconnect on (b)(6) 2023 and reported that infusion completed in 5 hrs.Pt presented to emergency dept on (b)(6) 2022 with complaints of chest abdominal pain status post syncopal episode.Expired on (b)(6) 2022.

• Brand Name: SMARTEZ ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; wha eastern seaboard; industrial estate 500/73 m.2; tasit amphur pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer (Section G): EPIC INTERNATIONAL (THAILAND) CO., LTD; wha eastern seaboard; industrial estate 500/73 m.2; tasit amphur pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer Contact: david lennarz ; 144 research drive; hampton, va 23666, usa; usa 23666 ; 7572240177
• MDR Report Key: 16529218
• MDR Text Key: 311144252
• Report Number: 3012429465-2023-00001
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 484041
• Device Catalogue Number: SE0005-270C
• Device Lot Number: C22E043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White