MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERFLOW 16G IV PORT INTER; APHERESIS PORT

Model Number A710962

Device Problems Restricted Flow rate (1248); Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: garrity, d., graves, m., linden, j., pierre, p.S., ducharme, p., zhao, y., ¿ weinstein, r.(2019).Performance characteristics of the powerflow apheresis port: early experience.Journal of clinical apheresis.Doi: 10.1002/jca.21743.

Event Description

It was reported in an article in the journal of clinical apheresis titled " performance characteristics of the powerflow apheresis port: early experience " that in a prospective study of four patients undergoing outpatient therapeutic plasma exchange (tpe), pressure alarm occurred in six of the forty seven procedures.It was further reported that the healthcare providers attempted to use very fast inlet flow rate, however, it was resolved by lowering the inlet flow rate by 10% in five of them.In patient number two, the pressure alarm occurred due to thrombus, however, it was resolved by pausing the procedure, aspirating and then flushing the port with saline.The current status of the patients was not provided.

• Brand Name: POWERFLOW 16G IV PORT INTER
• Type of Device: APHERESIS PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9167769
• MDR Text Key: 161730454
• Report Number: 3006260740-2019-02936
• Device Sequence Number: 1
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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