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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) no products are returning to the manufacturer.
 
Event Description
It was reported via a hot line call. The biomed is calling to have a pump checked out after a reported ruptured iab. According to biomed, there was no harm done to the patient related to the rupture and no blood was reported to have returned into the pump. The clinical support specialist (css)explained that she was the rn on call and would have field service contact the biomed to discuss further. The biomed had no further questions for the css. The field service agent is going to contact the biomed. Additional information received on 09/21/2016. Field service report l611503. Symptom: check if blood in pump. Found blood in pcs and interface block. Findings/action taken: catheter has blood to balloon connector - removed pcs need cotton swab to check inlet drain has clear fluid - looks like no blood to drain - cotton swab did pick up blood - bottom of balloon connection looks like blood - to have blood back up quote - sent in biomed knows of no patient problems. Fcn level: 1416, op
=
on patient confirmed. Additional information received on 10/03/2016. Fsr l611510. Symptom: replaced pump assy. - blood back up kit a second balloon and pump was used. No known patient harm. Findings / action taken: replaced pump assy. & all parts in blood back up kit performed functional checks - pass all. Fcn level: 1416, software level: 2. 24, op
=
on patient.
 
Manufacturer Narrative
(b)(4). No iap parts or recorder strips were returned for evaluation at the teleflex (b)(4) facility due to blood contamination. No further action required. The field service engineer followed up with the biomed and checked the pump out. Blood was confirmed in the inlet drain of the pcs assembly. The pump assembly and all parts in the blood backup kit were replaced. A functional checklist was performed and the pump passed all testing. 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: the details of the iab rupture are unknown. There was no further information received from the customer regarding when the pump became contaminated. 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 in pump" is confirmed. The field service engineer checked out the pump and used a blood backup kit to replace the contaminated parts. 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 hot line call. The biomed is calling to have a pump checked out after a reported ruptured iab. According to biomed, there was no harm done to the patient related to the rupture and no blood was reported to have returned into the pump. The clinical support specialist (css)explained that she was the rn on call and would have field service contact the biomed to discuss further. The biomed had no further questions for the css. The field service agent is going to contact the biomed. Additional information received on 09/21/2016; field service report (b)(4); symptom: check if blood in pump. Found blood in pcs and interface block. Findings/action taken: catheter has blood to balloon connector - removed pcs need cotton swab to check inlet drain has clear fluid - looks like no blood to drain - cotton swab did pick up blood - bottom of balloon connection looks like blood - to have blood back up quote - sent in biomed knows of no patient problems. Fcn level: 1416, op
=
on patient confirmed additional information received on 10/03/2016 - fsr (b)(4). Symptom: replaced pump assy. - blood back up kit. A second balloon and pump was used. No known patient harm. Findings / action taken: replaced pump assy. & all parts in blood back up kit performed functional checks - pass all. Fcn level: 1416, software level: 2. 24, op
=
on patient.
 
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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 Key6004307
MDR Text Key56938700
Report Number1219856-2016-00227
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
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 Received11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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