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

Model Number IMPAX CV 2.08

Device Problems Computer Software Problem (1112); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2015

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 97 different study dates in which an individual mdr report will be submitted for each associated study date and medical record number (mrn).Currently, 936 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.

Manufacturer Narrative

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 customization has revealed that this specific change had the potential to introduce clinical inaccuracies in patient reports.Specifically: the original sentence described the absence of deep or superficial thrombosis in either the lower or upper extremities - the change removed the "superficial" thrombosis, which was then added as a new section.Potential impact: if the change was made during the life of active rm, then if a previous report generated pre-change is used as a template, or a report generated pre-change is re-signed after the change, the clinical meaning of the sentence will change - where originally the report was of no evidence of deep operating room superficial thrombosis, it will now read only deep thrombosis.Clinically, the impact is negligible, as one normal part of the sentence still exists, and the worst is that it may cause confusion as to why the superficial vein is not being reported.The sentence still includes the verbiage that there is no evidence of dvt, but the verbiage of no evidence of superficial thrombosis is missing from this sentence and was added as a new section.As stated, there is little clinical risk as the documentation is this sentence change is not what the reading physician intended and should be corrected if found to be present in the production system.There has been no reported pt 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).

• Brand Name: IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION
• Manufacturer (Section D): AGFA HLTHCARE CORP; 1 crosswind rd.; misquamicut RI 02891
• Manufacturer Contact: deborah huff ; 10 s academy st; greenville, NC 29601 ; 8644211754
• MDR Report Key: 4468315
• MDR Text Key: 5181953
• Report Number: 1225058-2015-00100
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IMPAX CV 2.08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• 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