FDA Adverse Event Injury Summary report: N

PRISMAFLEX

MDR report key: 2467114 · Received February 15, 2012

Report

Report Number: 9616026-2012-00001
Event Type: Injury
Date Received: February 15, 2012
Date of Event: January 17, 2012
Report Date: January 17, 2012
Manufacturer: GAMBRO LUNDIA AB
Product Code: KDI
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: DA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE PRISMAFLEX CONTROL UNIT WITH SW 6.10 INVOLVED IN THIS EVENT DOES NOT HAVE 510 (K) CLEARANCE BUT IS SIMILAR TO PRISMAFLEX CONTROL UNIT SW 5.10 (510 (K) CLEARANCE K110823). A SIMULATED TREATMENT WAS PERFORMED BY A GAMBRO PRODUCT SPECIALIST FOLLOWING THE EVENT. NO MALFUNCTION WAS FOUND ON THE PRISMAFLEX CONTROL UNIT. THE ROOT CAUSE FOR THE UNINTENDED HEPARIN INFUSION IN THIS EVENT IS RELATED TO THE OPERATOR NOT HAVING SECURED THE SYRINGE IN THE PLUNGER CLAMP LATCH AS INSTRUCTED ON THE DISPLAY AND IN THE OPERATOR'S MANUAL. UNINTENTIONAL EMPTYING OF SYRINGES CONTENTS INTO THE EXTRACORPOREAL CIRCUIT IS EFFECTIVELY MITIGATED BY THE PLUNGER CLAMP LATCH ON THE PRISMAFLEX CONTROL UNIT.

Description of Event or Problem · 1

AN UNINTENDED HEPARIN INFUSION OCCURRED DURING A CVVHDF TREATMENT WITH A PRISMAFLEX CONTROL UNIT. THE VOLUME OF THE HEPARIN BOLUS THE PT RECEIVED WAS ESTIMATED TO BE 43 ML (HEPARIN CONCENTRATION 500 U/ML). THE PT DID NOT PRESENT WITH ANY CLINICAL SYMPTOMS OR BLEEDING AS A RESULT OF THE UNINTENDED HEPARIN INFUSION. THE PT'S ACTIVATED BLEEDING TIME (ACT) FOLLOWING THE BOLUS WAS 400 SECONDS. THE PT WAS GIVEN 10 ML PROTAMINE SULFATE (10 MG/ML) INTRAVENOUSLY. ACT RESULTS FOLLOWING ADMINISTRATION OF THE PROTAMINE WERE 145 SECONDS AND 119 SECONDS RESPECTIVELY. TREATMENT WAS CONTINUED ON THE SAME MACHINE FOLLOWING THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRISMAFLEX		KDI	GAMBRO LUNDIA AB	114489

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention