MAUDE Adverse Event Report: INFUTRONIX, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Lot Number 2002251632

Device Problems Insufficient Flow or Under Infusion (2182); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

The mother of patient (b)(6) reported that the patient had surgery on monday and his mother feels the bag is almost completely full.Rate-0.0.Vtbi-34.2.Vinf-265.8.Abvol-5.0.Maxh-16.0.Maxint-30.0.Qint-3hrs.Dbvol-5.0.Dblck-30min.When looking at the numbers and the 500ml bag should be approximately half empty but she said it is completely full.Patient's pain score 4-5/10 and also supplementing with oral pain medication.I did verify that the pump does appear to be infusing normally so for any further assistance with pain management i advised her to call the anesthesia team.

Manufacturer Narrative

Return of the device has been requested.As of the date of this report, device has not been returned.

Manufacturer Narrative

Analysis of the returned device is complete.The results are below: the pump was tested for an insufficient flow rate.The volume infused was 96.756ml.The programmed volume was 100 ml.So, the flow rate deviation is -3.244.This meets passing specification.Pump's dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Type of Device: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): INFUTRONIX, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): INFUTRONIX, LLC; natick MA 01760
• Manufacturer Contact: lorraine hanley ; 177 pine street; natick, MA 01760 ; 5083158230
• MDR Report Key: 17827186
• MDR Text Key: 324391864
• Report Number: 3011581906-2023-00181
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00817170020086
• UDI-Public: 00817170020086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 2002251632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1