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

Model Number 481012

Device Problem Failure to Infuse (2340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the descriptions of the event by user facility, it is evident that the device functions normally.There is no lot number, hence dhr review is not possible.

Event Description

Pt called on -call rn to reporthis daptomycin 600 mg/ ns 100 ml [se0200-100) not infusing and stated that he has been connected for 45 min and the ball has not gotten any smaller.It was supposed to run for 30 min.On-call rn instructed pt to disconnect the tubing from the picc, being careful not to touch the tips to see if there is any medication dripping.He reported to on-call rn that the medication was dripping.On-call rn instructed him / his wife to flush again with saline.Then reconnect the medication ano allow to infuse again.Pt instructed to call on-call rn if dose does not infuse.No return call from pt to on-call rn.Lot unk; device not available for return.

• Brand Name: SMARTEZ PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer (Section G): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer Contact: david lennarz ; registrar corp; 144 research drive; hampton, va 23666 ; 7572240177
• MDR Report Key: 8350464
• MDR Text Key: 136618794
• Report Number: 3012429465-2019-00058
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K151650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 02/12/2019

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
• Device Operator: Health Professional
• Device Model Number: 481012
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1