MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. VASCULAR POSITIONING SYSTEM; VPS G4 SYSTEM

Catalog Number VPS-G4C

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the customer is receiving a steady negative orange symbol on the vps even when the insertion begins.They are placing the catheters by using p-wave and doppler.The vps gave orange negative most of the entire case.A chest x-ray was taken and the catheter was in the svc.After calibration and during the procedure post flush test they are receiving an orange do not enter symbol with perfect ecg and doppler that finally ended with a blue bullseye.Chest x-ray confirmed they were in the svc-caj.It was noted they were using vps7220b from lot 73b1600224.

Manufacturer Narrative

(b)(4).Device evaluation: the report the customer is receiving a steady negative orange symbol on the vps even when the insertion begins was confirmed.One sample (console unit (b)(4) and accessories) was returned for evaluation.The visual evaluation determined the returned unit was in acceptable condition.The unit was connected and vps g4 console power-on test was performed.The results of the test were acceptable which indicated the unit performed as intended.The data set shown in attachments was not on the unit and was not available for review.Eight other data sets were on the unit and were given to a vps senior algorithm scientist for analysis.A vps senior algorithm scientist reviewed all eight data sets and determined dataset one of the eight was representative of the reported event.The doppler baseline data showed the level of electromagnetic interference (emi) was very high.Emi disturbance degrades and limits the effective performance of the vps system.This high level of emi could be from hospital environment and/or other medical devices, which radiate excessively high radiofrequency energy, nearby the vps operation location at the same time.The procedure data showed the high level of emi in the retrograde doppler flow area (steady white line) and the high power level of other remarks: the noise signal in the retrograde caused the system to display orange symbol.The vps senior algorithm scientist concluded the vps system displayed a steady orange stop symbol with good ecg and doppler signal due to the excessive noise on the doppler mainly caused by the environmental condition during the vps console's operation.The device history record review was performed and no evidence was found to indicate a manufacturing related cause.Operational context caused or contributed to this event because the work environment created the excessive noise on the doppler.

• Brand Name: VASCULAR POSITIONING SYSTEM
• Type of Device: VPS G4 SYSTEM
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5578742
• MDR Text Key: 42750719
• Report Number: 3003898360-2016-00432
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPS-G4C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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