MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM INFUSION PUMP; PUMP, INFUSION

Catalog Number 35700BAX2

Device Problem No Flow (2991)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received and evaluated for a different reported issue.The pump is no longer in the as received condition and there is no opportunity to evaluate for the reported symptom 'did not infuse'.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The cause of the condition could not be determined.The device will be tested prior to return to the customer to ensure all specifications are met.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a spectrum pump did not infuse during therapy in the intensive care unit.No abnormalities were observed in the tubing or intravenous line.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: SPECTRUM INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16902073
• MDR Text Key: 314902285
• Report Number: 1314492-2023-01639
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412498683
• UDI-Public: (01)00085412498683
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 35700BAX2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1