MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD AC PUMP POWER CORD CSA GREY; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 400-100678

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an ac pump power cord for the main module of an unspecified acd hardware device was frayed.The reporter stated that one of the internal wires was exposed as the rubber coating had been cut.There was no patient involvement.No additional information is available.

• Brand Name: AC PUMP POWER CORD CSA GREY
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6545956
• MDR Text Key: 74477668
• Report Number: 1416980-2017-03880
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400-100678
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2017
• 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