FDA Adverse Event Malfunction Summary report: N

CADD-SOLIS VIP AMBULATORY INFUSION PUMP

MDR report key: 19852940 · Received July 29, 2024

Report

Report Number: 3012307300-2024-06787
Event Type: Malfunction
Date Received: July 29, 2024
Date of Event: June 29, 2024
Report Date: September 3, 2024
Manufacturer: SMITHS MEDICAL ASD, INC.
Product Code: FRN
PMA / PMN Number: K111275
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

H3: PRODUCT WAS NOT RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED TO AID IN THIS INVESTIGATION. UNABLE TO CONFIRM IF PREVIOUS REPAIR IS RELATED TO THE CURRENT COMPLAINT AS NO DEVICE WAS RETURNED. PRODUCT EVALUATION AND PROBLEM CONFIRMATION CANNOT BE PERFORMED. ERROR HISTORY LOG WAS NOT PROVIDED. PROBABLE CAUSE COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 0

(B)(6) INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PUMP WAS ALARMING AIR IN LINE. PER REPORTER, THE ALARM WAS ACKNOWLEDGED AND SETTINGS REVIEWED. RES VOL 92ML, RATE 2ML/HR, GIVEN 90.5ML SINCE (B)(6)2024 (NOT CLEARED BY FACILITY.) INFUSION WAS STARTED (B)(6) AT APPROXIMATE 14:00, AND DISCONNECT APPOINTMENT SCHEDULED FOR 14:15. THERE IS NO VISIBLE AIR BUBBLES WITHIN THE TUBING. PERE REPORTER, THE PUMP WAS POWERED OFF AND THEY WERE UNABLE TO REMOVE THE CASSETTE AS IT WAS LOCKED INTO PLACE BY FACILITY. THERE IS NO SFI ON FILE AND THE PATIENT WAS INSTRUCTED TO CONTACT THE CLINIC FOR ASSISTANCE. THEY WERE UNABLE TO CLOSE CLAMPS ON TUBING. NO PATIENT HARM/ADVERSE EVENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
371347	CADD-SOLIS VIP AMBULATORY INFUSION PUMP	PUMP, INFUSION	FRN	SMITHS MEDICAL ASD, INC.	2120

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown