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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 Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field service report (b)(4). Symptom: pump giving 20 minute alarm after running for 30 minutes on battery. Per the hospital biomed the pump was switched off the patient quickly. Iap therapy was completed as planned. No patient complications or other intervention was required. Findings/action taken: batteries sent to and replaced by hospital biomed. Fcn level: (b)(4), software level: 2. 24.
 
Manufacturer Narrative
(b)(4). Evaluation: teleflex received the affected batteries for analysis. They were tested using a known good autocat2w and a digital multi-meter amp2-154 was used and the battery load test was performed. The battery (l/n: 18f16c0033) passed the load test with no accuracy problems found. The battery (l/n: 18f15k0033) failed a battery load test. A careful visual inspection was also performed and no abnormalities were noted. The root cause of the premature battery failure is unknown. Teleflex assessed the risk for the reported complaint and determined that there are no new or revised risks. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex will continue to monitor for similar reports of this issue. Other remarks: the reported complaint of the battery alarm was confirmed on one of the two returned batteries. No actions are planned at this time.
 
Event Description
It was reported via (b)(4). Symptom: pump giving 20 minute alarm after running for 30 minutes on battery. Per the hospital biomed the pump was switched off the patient quickly. Iap therapy was completed as planned. No patient complications or other intervention was required. Findings/action taken: batteries sent to and replaced by hospital biomed. Fcn level: 1416, software level: 2. 24.
 
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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
carmen sherman
3015 carrington mill blvd
morrisville, PA 27560
6104783117
MDR Report Key6124252
MDR Text Key60764864
Report Number1219856-2016-00276
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 10/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated by Manufacturer? Yes
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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