AUTOCAT2 WAVE

MDR report key: 1881149 · Received October 1, 2010

Report

Report Number: 1219856-2010-00689
Event Type: Malfunction
Date Received: October 1, 2010
Date of Event: September 21, 2010
Report Date: September 28, 2010
Manufacturer: ARROW INTERNATIONAL, INC.
Product Code: DSP
PMA / PMN Number: K060309
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT IN THE CARDIAC CARE UNIT (CCU), A PATIENT IN CARDIOGENIC SHOCK WAS ON AN INTRA-AORTIC BALLOON PUMP (IABP). IT HAD ALARMS OF DRAIN FAILURE. THE NURSE CALLED THE CLINICAL SUPPORT SPECIALIST (CSS), THE PATIENT HEART RATE WAS IN THE 130'S AND THE CONDENSATION BOTTLE WAS EMPTY. THE STAFF HAD EMPTIED APPROXIMATELY ONE INCH OF CONDENSATION AND THE ALARM RECURRED AFTER APPROXIMATELY 20 MINUTES. THE ALARM HAS OCCURRED EVERY 20 MINUTES SINCE INSERTION. A MANUAL PURGE WAS COMPLETED AND IT ALARMED WITHIN A MINUTE. THE CSS CALLED THE FIELD SERVICE REPRESENTATIVE TO CONFIRM THERE COULD BE A VALVE PROBLEM. THE IABP WAS SWITCHED TO ANOTHER AUTOCAT2 WAVE AND SENT TO BIOMED. THE STAFF WAS WALKED THROUGH FIBEROPTIX SENSOR MAP CAL AND PROBLEM FIXED WITH NO FURTHER QUESTIONS. THERE WAS NO PATIENT DEATH, INJURIES OR COMPLICATIONS. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 9/22/2010 FROM THE SALES REPRESENTATIVE STATED THAT THE PATIENT BLOOD PRESSURE WAS TOO LOW TO TOLERATE THE DRUGS TO LOWER HEART RATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOCAT2 WAVE	INTRA-AORTIC BALLOON PUMP PRODUCTS	DSP	ARROW INTERNATIONAL, INC.		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK