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

Model Number	480041
Health Effect - Clinical Code	Overdose (1988)
Date of Event	01/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record for this lot did not show any flow rate issue.This is confirmed by flow rate testing on retained samples on 2020-02-11.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
Patient reported that smartez pump that should have infused over 24 hr completed in about 12 hrs.Medication dispensed in the 10ml/hr, 270ml fill smartez pump.The facility retrieved seven pumps from the patient.One ran fast, the remaining were retrieved for qa.Seven devices available for evaluation.(although awareness date was 1/11, complete information was not available til 1/24).

• 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: 9801646
• Report Number: 3012429465-2020-00001
• Device Sequence Number: 2078332
• Product Code: MEB
• UDI-Device Identifier: 18859299100040
• UDI-Public: (01)18859299100040(10)S9B30(17)220128(11)190228(241)SE0010-270
• 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: Pharmacist
• 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: 01/28/2022
• Device Model Number: 480041
• Device Lot Number: S9B30
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• 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