MAUDE Adverse Event Report: TELEFLEX MEDICAL ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB; PUMP, INFUSION, ELASTOMERIC

Catalog Number MVBXL-CPNB

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer returned one autofuser of catalog number mvbxl-cpnb af w/as 550 x 1-14ml/hr cpnb for analysis, lot a190329-pscfb000us-1.Visual inspection revealed that the autoselector was set at 0ml/hr and that the balloon was filled with solution.During the visual and microscopic inspections, the tubing on the bottom of the autoselctor was inspected for damage.The reported complaint of the tubing separated was confirmed during the visual and microscopic inspections.During the inspections, it was observed there to be a bonding/glue issue between the tubing and the tube attached to the bottom of the autoselector.Based on the result of this investigation , the root cause is undetermined and the sample will be forwarded to the supplier to further investigate.

Event Description

Customer reported the tubing separated below the autoselector dial.The patient's pump was replaced.No patient harm reported.

• Brand Name: ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 9506571
• MDR Text Key: 194824857
• Report Number: 3004365956-2019-00373
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2019

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: No Information
• Device Catalogue Number: MVBXL-CPNB
• Device Lot Number: A190329-PSCF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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