FDA Adverse Event Malfunction Summary report: N

QTM LEVEL SENSOR 2.0M - SINGLE HEAD

MDR report key: 22607334 · Received July 25, 2025

Report

Report Number: 3006073153-2025-00182
Event Type: Malfunction
Date Received: July 25, 2025
Date of Event: June 26, 2025
Report Date: July 25, 2025
Manufacturer: SPECTRUM MEDICAL LTD
Product Code: DRY
UDI-DI: 05060434421890
PMA / PMN Number: K173591
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION OF THE LOGS CORROBORATE THE EVENTS DESCRIBED BY THE USER. NO PHYSICAL DAMAGE FOUND ON THE DEVICE, FURTHER FUNCTIONALITY TESTING FOUND NO ISSUE, THE LEVEL SENSOR TRIGGERED AS EXPECTED. ROOT CAUSE SUSPECTED TO BE AN IMPROPERLY ATTACHED LEVEL SENSOR CRADLE (HOLDS LEVEL SENSOR AGAINST RESERVOIR).

Description of Event or Problem · 0

USER REPORTED THAT DURING A CASE, THE PUMP WAS STOPPED AS THE SAFE FLOW BUBBLE DETECTOR HAD TRIGGERED. THE USER NOTICED THAT THE LEVEL SENSOR HAD NOT RECOGNISED THAT THE RESERVOIR LEVEL HAD DROPPED BELOW THE PROTECTED LEVEL WHICH SHOULD HAVE STOPPED THE PUMP PRIOR TO THE SAFE FLOW BUBBLE DETECTOR. ONCE THE PUMP STOPPED, THE RESERVOIR VOLUME RETURNED, THE SAFE FLOW BUBBLE ALARM WAS CLEARED, THE PUMPED RESTARTED AND THE CASE CONTINUED WITHOUT ISSUE. THE PUMP WAS STOPPED FOR LESS THAN 20 SECONDS. TESTING THE LEVEL SENSOR AFTERWARDS, THE USER PHYSICALLY MANIPULATED THE SENSOR AND SAW THE LEDS INTERMITTENTLY FLASH ON AND OFF. THE USER OPTED TO CHANGE OUT THE LEVEL SENSOR. THERE WAS NO PATIENT HARM AS A RESULT OF THIS ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2286975	QTM LEVEL SENSOR 2.0M - SINGLE HEAD	RESERVOIR LEVEL SENSOR	DRY	SPECTRUM MEDICAL LTD	QLS1-200		05060434421890

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown