MAUDE Adverse Event Report: AGFA HEALTHCARE CORP. IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08); PICTURE ARCHIVING AND COMMUNICATION

Model Number IMPAX CV RM 2.08

Device Problem Installation-Related Problem (2965)

Patient Problem No Information (3190)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

Agfa submitted mdr report # 1225058-2010-00001 to the fda on june 7, 2010 for a site in the us.A 14th occurrence is being reported for the same issue/same device: impax cv results management administration tool (rmat).Within this 14th occurrence are 2 different study dates in which an individual mdr report will be submitted for each study date and medical record number (mrn).Currently, only two reports contain this incorrect finding information.This is an internal discovery determined during the implementation of the associated problem correction plan, rmat verification, as reported in fda z-2112-10.An agfa clinical analyst performed a retro-analysis and reported the findings to agfa service and agfa product quality manager.Agfa's investigation into this occurrence of rmat customizations has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: label was changed from truncal v regurg p 1/2-time to pulmonary insufficiency pressure half time (pi pht).Potential impact: if the change was made after reports had been generated those reports prior to the change could display incorrect clinical data if viewed in rm or if used as a template for a repeat study on that patient - in this example the two disease states are very different, leading to potential incorrect diagnosis.Description of measurement does not correlate when using hover tool which can cause confusion.Truncus arteriosus is a rare heart defect that's present at birth (congenital).In truncus arteriosus, it means that one large blood vessel leads out of the heart.Normally, there are two separate vessels coming out of the heart.After a (b)(6) is treated for truncus arteriosus, he/she can develop truncal valve stenosis and or truncal valve regurgitation.Pulmonary valve insufficiency (or incompetence, or regurgitation) is a condition where the pulmonary valve is not strong enough to prevent backflow to the right ventricle.If it is secondary to pulmonary hypertension it is referred to as a graham steell murmur.The three primary pathological mechanisms causing pulmonary valve insufficiency are dilatation of the pulmonic valve ring, acquired alteration of pulmonic valve leaflet morphology, or congenital absence or malformation of the valve.There has been no reported patient harm for this occurrence.A reportable correction is underway for this issue and has been reported to the fda via reference # z-2112-10.Agfa will follow the rmat post market verification work instructions to correct the sentence finding.Any further investigation for the site described in this report will be documented in the ongoing cfr part 806 reporting.(b)(6).

Manufacturer Narrative

(b)(4).

• Brand Name: IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION
• Manufacturer (Section D): AGFA HEALTHCARE CORP.; 1 crosswind rd; misquamicut RI 02891
• Manufacturer (Section G): AGFA HEALTHCARE CORP.; 1 crosswind rd; misquamicut RI 02891
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4388076
• MDR Text Key: 15972916
• Report Number: 1225058-2015-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IMPAX CV RM 2.08
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2002
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1