MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD PRE-AMP CABLE, SPM-1 CONNECTS MONITOR TO CATHETE; N/A

Catalog Number PAC2

Device Problems Signal Artifact/Noise (1036); Grounding Malfunction (1271); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This is the eighth of twelve reports (same reporter, same problem, same product id, different serial numbers).It was reported that the receptacle that engages the catheter was not connected to the ground.When touched, the mpm-1 monitor showed an interference and the spm-1 monitor showed an error.A multimeter was used to check this problem.The cables are new and never been used.The issue was discovered by the distributor.There was no patient involvement.

Manufacturer Narrative

Integra has completed their internal investigation on 20apr2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: cables tested within specifications.The failure analysis investigation encompassed visual inspection, functional testing and review of videos provided by the customer.The customer reported that the monitor shows interference at mpm-1; pac2 cables are designed to be used with spm-1 monitor and not mpm-1 monitor.The customer communicated that the mpm-1 monitor was used for ¿better view of the problem in graphic¿, thus it can be concluded that the reported failure is not related to pac2 cables.The customer reported that the monitor show error in spm-1; calibration records of spm-1 monitors used by the customer for pac2 cables incoming inspection testing were reviewed; last service history record on integra system was for preventative maintenance on 06-sep-2006.It was noted that the calibration of spm-1 monitors is carried out annually by a trained calibration technician from customer¿s repair centre, however no training record or spm-1 monitor calibration record was provided by the customer for review.The videos provided by the customer illustrated an issue with ¿no continuity¿; pac2 cables were modified in 2009/2010 to modification level 2 so that the grounding is clipped back to the outer sheath resulting in no continuity; all returned pac2 cables were manufactured as modification level 2 based on the date of manufacture, thus no impact on issue with continuity.Review of dhr documentation of serial numbers of good cables provided by the customer was completed; ¿good cables¿ were manufactured pre re-design change as modification level 1, thus would show continuity and would have no impact on complaint incident.Finally, it was noted that the customer is concerned about the radio and tv transmission towers located in close proximity to test facility.Based on the information provided by the customer, the towers which generate a strong radio frequency may be a contributory factor to the complaint incident, thus a possible impact on complaint incident.The analysis of the complaint investigation identified no issue.All results of the functionality tests were recorded as within specification and final release checks were performed satisfactory prior to the cable been released.The complaint incident was initiated for monitor cable pac2 therefore there is no service history to be reviewed.The dhr review has been deemed satisfactory.A minimum of 12 month review of pac2 cable customer complaints was completed using the following key words ¿cable to monitor connection failure¿ and a root cause ¿could not duplicate¿ in the search criteria.This review encompassed from dates 11-nov-2014 to 11-apr-2016.A total of (b)(4) complaints were reviewed of which (b)(4) complaints met the search criteria.The analysis of the complaint investigations and root cause reports has concluded complaint incident is the (b)(4) identified complaint for the reported failure associated with pac2 cable that could not be duplicated.Since the complaint incident could not be duplicated and the pac2 cables were verified as working within specifications, no root cause can be established.Linked to mfg report numbers: 8010219-2015-00053, 8010219-2015-00062, 8010219-2015-00051, 8010219-2015-00052, 8010219-2015-00054, 8010219-2015-00055, 8010219-2015-00056, 8010219-2015-00058, 8010219-2015-00059, 8010219-2015-00060, 8010219-2015-00061.

• Brand Name: PRE-AMP CABLE, SPM-1 CONNECTS MONITOR TO CATHETE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD; newbury road; newbury road; andover hampshire ; UK
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; newbury road; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5250203
• MDR Text Key: 32305305
• Report Number: 8010219-2015-00057
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K031086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PAC2
• Device Lot Number: TL-325153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1