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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number N/A
Device Problems Device Stops Intermittently (1599); Malposition of Device (2616); Application Program Problem (2880); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number. Device has not yet been returned for evaluation.
 
Event Description
Per biomed, site rite 8 (b)(4) - end users are complaining that sr 8 system is making a random beeping noise that they cannot pinpoint where it is coming from. System's battery is full when beeping occurs. They also reported that the touch screen is intermittently non-functional. Nurse also reported that during one procedure, while advancing the picc in sherlock mode, the green diamond never appeared to indicate that they were in the correct position. This caused the user to place the picc too far. Confirmation was done through cxr.
 
Event Description
Per biomed, site rite 8 (sn (b)(4)) - end users are complaining that sr 8 system is making a random beeping noise that they cannot pinpoint where it is coming from. System's battery is full when beeping occurs. They also reported that the touch screen is intermittently non-functional. Nurse also reported that during one procedure, while advancing the picc in sherlock mode, the green diamond never appeared to indicate that they were in the correct position. This caused the user to place the picc too far. Confirmation was done through cxr.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation. During evaluation, the reported issue of inaccurate ecg readings was unconfirmed. The sherlock software was tested with an internal use sherlock sensor and sherlock test fixture; the green diamond did appear during this test. The customer sherlock is not with the system for a complete test. The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation. No other functionality issues with the equipment were found during evaluation/servicing. The device was serviced, tested, and returned to the customer. A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
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Brand NameSITE-RITE 8 ULTRASOUND
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7367579
MDR Text Key103532707
Report Number3006260740-2018-00520
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number9770500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2018
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/29/2019
Is This a Reprocessed and Reused Single-Use Device? No

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