MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP SPECTRUM INFUSION PMP; INFUSION PUMP

Model Number 35700

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/01/2015

Event Type  malfunction  

Event Description

It was reported that a spectrum pump's door was hard to close in the medical surgical care area.It was also reported there was no pt injury.

Manufacturer Narrative

(b)(4).The device has been received by baxter for eval.The eval has not been completed at this time.A supplemental report will be provided when the investigation is completed.

• Brand Name: SPECTRUM INFUSION PMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): BAXTER HEALTHCARE CORP; medina NY
• Manufacturer Contact: kelly morse, sr. mgr, quality ; 711 park ave.; medina, NY 14103 ; 8003563454
• MDR Report Key: 4490650
• MDR Text Key: 15321423
• Report Number: 1314492-2015-01756
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35700
• Device Catalogue Number: 35700
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• Date Device Manufactured: 02/05/2011
• 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