FDA Adverse Event Malfunction Summary report: N

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

MDR report key: 8675179 · Received June 6, 2019

Report

Report Number: 3012307300-2019-03399
Event Type: Malfunction
Date Received: June 6, 2019
Report Date: June 6, 2019
Manufacturer: SMITHS MEDICAL ASD, INC.
Product Code: FRN
UDI-DI: 15019517096378
PMA / PMN Number: K111275
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVAL: ONE SMITHS MEDICAL CADD-SOLIS VIP AMBULATORY INFUSION PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP SHOWED THE TAMPER SEAL WAS MISSING AND THE LENS WAS DAMAGED. REVIEW OF THE EVENT HISTORY LOG SHOWED THE PUMP DISPLAYED THE FOLLOWING EVENTS: "(B)(6) 2005 12:00:08 AM MEDIUM ALARM DISPLAYED: PUMP SETTINGS AND PATIENT DATA LOST. ON (B)(6) 2005 12:00:30 AM MEDIUM ALARM ACKNOWLEDGED: PUMP SETTINGS AND PATIENT DATA LOST. ON (B)(6) 2005 7:54:00 AM TIME CHANGED FROM (B)(6) 2005 12:00:48 AM TO (B)(6) 2005 7:54:00 AM. ON (B)(6) 2005 7:54:00 AM START TIME CHANGED FROM (B)(6) 2005 12:00:00 AM TO (B)(6) 2005 7:53:12 AM" THE PUMP WAS POWERED UP AND THE REPORTED ISSUE WAS REPLICATED. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THAT THE REAL TIME CLOCK BATTERY HAD BROKEN AWAY FROM THE BOARD DUE TO A FALL. ACCORDING TO THE INVESTIGATION, THIS ISSUE WAS A RESULT OF THE CUSTOMER'S PHYSICAL DAMAGE TO THE DEVICE. BEYOND DEVICE REPAIR, NO FURTHER ACTION WILL BE TAKEN ON THIS ISSUE.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD-SOLIS VIP AMBULATORY INFUSION PUMP'S SETTINGS AND PATIENT DATA WERE LOST. NO ADVERSE EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
470481	CADD-SOLIS VIP AMBULATORY INFUSION PUMP	PUMP, INFUSION	FRN	SMITHS MEDICAL ASD, INC.	2120		15019517096378

Patients

Seq	Age	Sex	Outcome	Treatment
1