FDA Adverse Event Malfunction Summary report: N

AQUALINE

MDR report key: 2062617 · Received April 19, 2011

Report

Report Number: 1423500-2011-04681
Event Type: Malfunction
Date Received: April 19, 2011
Date of Event: April 2, 2011
Report Date: April 3, 2011
Manufacturer: HAEMOTRONIC
Product Code: FJK
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE HAS BEEN RECEIVED , AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS EVALUATED BY BAXTER AND HAEMOTRONIC AND CONFIRMED THAT THE PRESSURE DOME WAS DAMAGED AND MISSING 5 TEETH. FURTHER INVESTIGATION BY HAEMOTRONIC SHOWED THAT THIS DEFECT COULD NOT HAVE OCCURRED DURING THE MANUFACTURING PROCESS. TWO (2) OF THE MISSING TEETH WERE FOUND IN THE POUCH, AND THERE APPEARED TO BE DAMAGE TO THE OVERPOUCH; THEREFORE HAEMOTRONIC DETERMINED THAT THIS WAS NOT A PRODUCTION PROBLEM. ROOT CAUSE COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 1

(B)(4)

Description of Event or Problem · 1

A NURSE REPORTED TO BAXTER (B)(4) THAT THE PRESSURE DOME (YELLOW LINE) WAS DAMAGED WHEN REMOVING IT FROM THE OVERPOUCH. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AQUALINE	SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE	FJK	HAEMOTRONIC		B103384

Patients

Seq	Age	Sex	Outcome	Treatment
1