AUTOCAT 2 WAVE GERMAN

MDR report key: 2432052 · Received January 3, 2012

Report

Report Number: 1219856-2011-00483
Event Type: Malfunction
Date Received: January 3, 2012
Date of Event: December 19, 2011
Report Date: December 28, 2011
Manufacturer: ARROW INTL., INC.
Product Code: DSP
PMA / PMN Number: K060309
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PUMP WAS CHECKED BY A THIRD PARTY WITH NO RELEVANT FINDINGS.

Description of Event or Problem · 1

SEE MDR 1219856-2011-00484 FOR THE IAB. IT HAS BEEN REPORTED THAT THE EVENT INVOLVED A MALE PATIENT WHILE IN THE CATH LAB WHEN THE PUMP WAS STARTED. RELEVANT MEDICAL HISTORY/DIAGNOSIS: CARDIOGENIC SHOCK (CS). WHEN THE PUMP WAS STARTED A "HELIUM LOSS ALARM" OCCURRED. NO BLOOD WAS VISIBLE IN THE HELIUM LINE. THE IAB AND HELIUM LINE WERE CHECKED FOR POSSIBLE KINKS; NONE OBSERVED. NO ANATOMICAL ABNORMALITIES ON PATIENT, PATIENT HAD SINUS RHYTHM. SEVERAL ATTEMPTS WERE MADE TO START THE PUMP WITHOUT SUCCESS. AS A RESULT, THE IAB AND SHEATH WERE REMOVED AS ONE UNIT SUCCESSFULLY. A NEW IAB WAS INSERTED AND THE PUMP WAS SWITCHED. THERAPY WAS FINISHED. NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY WITH NO CAUSE HARM TO THE PATIENT NOTED. THE PATIENT OUTCOME IS OKAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOCAT 2 WAVE GERMAN	INTRA-AORTIC BALLOON PUMP PRODUCTS	DSP	ARROW INTL., INC.		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			INTRA-AORTIC BALLOON CATHETER