MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VPS RHYTHM MONITOR BUNDLE - REFURBISHED; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037512
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports tip placements checked by chest x-ray are inconsistent with readings provided by the vps rhythm.No patient harm reported.
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
Customer reports tip placements checked by chest x-ray are inconsistent with readings provided by the vps rhythm.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4).Vps rhythm monitor s/n: (b)(6) with accessories was returned.A hugo service engineer performed the evaluation as documented in service report (b)(6) 20 jan 2022.A visual examination revealed the monitor enclosure is damaged.It was reported "tip placements checked by cxr inconsistent with readings provided by vps rhythm".A function test was carried out which the monitor passed without any faults.The lemo, stereo, and remote cables were all manipulated but no faults occurred.The monitor maintained a steady reading of 60bpm and all of the waveforms were consistent.The t-piece and stylet were performing as they should during the external test.The reported issue was not reproduced.No problem was found with the functionality of the returned monitor.A device history record review was performed and did not reveal any manufacturing or servicing related issues.The reported issue "tip placements checked by cxr inconsistent with readings provided by vps rhythm" was not confirmed by evaluation of returned vps rhythm monitor s/n: (b)(6) with accessories.A visual examination revealed the monitor enclosure is damaged.During functional testing, the monitor passed without any faults.The lemo, stereo, and remote cables were all manipulated but no faults occurred.The monitor maintained a steady reading of 60bpm and all of the waveforms were consistent.The t-piece and stylet were performing as they should during the external test.The reported issue was not reproduced.No problem was found with the functionality of the returned monitor.No further action will be taken.
Event or Problem Description
Customer reports tip placements checked by chest x-ray are inconsistent with readings provided by the vps rhythm.No patient harm reported.

• Brand Name: ARROW VPS RHYTHM MONITOR BUNDLE - REFURBISHED
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12912858
• Report Number: 3011137372-2021-00323
• Device Sequence Number: 4946252
• Product Code: LJS
• UDI-Device Identifier: 10801902127881
• UDI-Public: 10801902127881
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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 Expiration Date: 08/08/2021
• Device Model Number: IPN037512
• Device Catalogue Number: RHY-100-MTRB-R
• Device Lot Number: R10118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/28/2021; 01/26/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/04/2022; 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown