• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sample is not expected to be returned.
 
Event Description
It was reported via a field service report: (b)(4). Symptom: pump has been contaminated with blood. Biomed noticed blood in pump. It's unknown when contamination occurred. Findings / action taken: replace blood contamination parts. (b)(4), software level: 2. 24 op
=
on patient confirmed additional information received 06/13/2016 the pump alarmed system error 3 while on a patient. The pump was exchanged off the patient without event.
 
Manufacturer Narrative
(b)(4) no iap parts or recorder strips were returned for evaluation at the (b)(4) teleflex facility. Per the field service report, blood backup was noted in the pump by the biomed. The field service engineer checked the pump and replaced all contaminated parts. A pm was performed and the pump passed all testing. The pump was operational and returned to service. Blood can only enter the iabp from an iab that develops a leak. The ifu states: "intra-aortic balloon membrane perforation may occur during iabp therapy. The occurrence and severity of the iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation. Large perforations are rare. Small perforations can result in asymptomatic release of gas. Perforation can cause blood to appear in the balloon catheter and driveline tubing. " further the ifu states: 'if you suspect balloon perforation: immediately stop pumping. Consider tapering or discontinuing anticoagulation therapy. Remove iab from patient, using recommended removal technique" see other remarks section. Other remarks: additional information received from the hospital biomed stated that a system error 3 alarm occurred and the pump was switched off the patient. A system error 3 alarm indicates that the communication between cpu & pump controller has been lost/ pump valve controller failure. The details of the iab rupture are unknown. There was no further information received from the customer regarding when the pump became contaminated. No iap parts or recorder strips were returned for evaluation at the teleflex (b)(4) facility due to blood contamination. No further action required. A device history record (dhr) review was conducted for the iap serial/lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of "blood back up in the pump" is confirmed. The field service engineer checked the pump and confirmed there was blood in the pump. The contaminated parts were replaced by the field service engineer. The details when the pump was contaminated are not clearly known. No pump parts were returned for evaluation. The cause of the damaged pump was most likely the result of a catheter/balloon leak.
 
Event Description
It was reported via a field service report: (b)(4). Symptom: pump has been contaminated with blood. Biomed noticed blood in pump. It's unknown when contamination occurred. Findings / action taken: replace blood contamination parts. Fcn: 1416, software level: 2. 24. Op
=
on patient. Confirmed. Additional information received 06/13/2016. The pump alarmed system error 3 while on a patient. The pump was exchanged off the patient without event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAUTOCAT2 WAVE
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5742822
MDR Text Key47968630
Report Number1219856-2016-00146
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K60309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot Number0001028083
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-