FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 3251220 · Received July 29, 2013

Report

Report Number: 1416980-2013-19967
Event Type: Malfunction
Date Received: July 29, 2013
Report Date: July 2, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: FPA
PMA / PMN Number: K961225
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE EXACT OCCURRENCE DATE IS UNKNOWN; HOWEVER, IT IS KNOWN THAT THE EVENT OCCURRED PRIOR TO (B)(6) 2013. ADDITIONAL INFORMATION: THE INTRAVENOUS ADMINISTRATION SET WAS IDENTIFIED MORE SPECIFICALLY AS A CLEARLINK CONTINU-FLO SOLUTION SET. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION CONFIRMED THAT THE TUBING WAS SEPARATED FROM THE DRIP CHAMBER. UPON CLOSER INSPECTION IT WAS IDENTIFIED THAT THERE WAS NO VISIBLE SOLVENT PLOW RIDGE. THE OTHER SOLVENT BONDS WERE PULL-TESTED; NO OTHER FAILURES WERE DETECTED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED.

Additional Manufacturer Narrative · 1

(B)(4). INITIAL INSPECTION OF THE SAMPLE CONFIRMED THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN INTRAVENOUS ADMINISTRATION SET HAD THE TUBING SEPARATE, FROM A BONDED JUNCTURE BELOW THE DRIP CHAMBER. THE SET WAS CONNECTED TO A BAG OF LACTATED RINGERS WITH ADDED OXYTOCIN. THE EVENT OCCURRED IN THE OBSTETRICS DEPARTMENT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352539	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				LACTATED RINGERS, OXYTOCIN