FDA Adverse Event Malfunction Summary report: N

ARTERIAL LINE NON-MACHINE SPEC 8MM NO D

MDR report key: 212995 · Received March 1, 1999

Report

Report Number: 8030665-1999-00033
Event Type: Malfunction
Date Received: March 1, 1999
Date of Event: January 27, 1999
Report Date: February 3, 1999
Manufacturer: ERIKA DE REYNOSA
Product Code: FJK
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NURSE

Narratives

Description of Event or Problem · 1

REC'D NOTICE OF COMPLAINT CONCERNING ABOVE PRODUCT FROM CLINICAL VARIANCE FORM FILED BY FACILITY DIRECTOR OF NURSING. REPORTS 3 EVENTS IN WHICH A LEAK OCCURRED AT THE (PRE) PUMP SEGMENT TO PUMP ADAPTER CONNECTION. STATES THAT IN ALL 3 EVENTS, THE LEAK OCCURRED AT THE BEGINNING OF THE TREATMENT AND AIR WAS PULLED INTO THE SYSTEM. UNABLE TO RETURN THE BLOOD IN THE ARTERIAL LINE. THE LINES WERE CHANGED AND THE TREATMENTS WERE COMPLETED WITHOUT FURTHER INCIDENT. THE BLOOD LOSS FOR THESE 3 PTS WAS REPORTED AS APPROX 50CC. THERE WAS NO FURTHER INJURY REPORTED AND NONE OF THE PTS REQUIRED MEDICAL INTERVENTION. ALL THREE EVENTS WERE ISOLATED TO THE REPORTED LOT NUMBER. THE ACTUAL SAMPLES WERE DISCARDED ON THE DAY OF THE EVENT, BUT THE FACILITY HAS COMPANION SAMPLES. DIRECTOR OF NURSING REPORTS THAT THE DEFECT IS VISIBLE IN THE COMPANION SAMPLES, INSTRUCTED TO MARK AREA. ALSO, REPORTS THAT THEY HAVE REMOVED THIS LOT NUMBER FROM STOCK. A RESPONSE LETTER AND MAILER HAVE BEEN SENT. MEDWATCH FORMS HAVE BEEN FILED BASED ON BLOODLOSS ONLY. REFERENCE PIR#'S 9900261 & 9900262.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARTERIAL LINE NON-MACHINE SPEC 8MM NO D	BLOODLINE FOR HEMODIALYSIS	FJK	ERIKA DE REYNOSA	NA	R8J145

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other	FRESENIUS 2008H DIALYSIS MACHINE.\| F70 DIALYZER,