MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0400

Device Problems Device Alarm System (1012); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device / parts will not be returned for evaluation.

Event Description

It was reported per field service report: symptom - vacuum failure finding/action taken: replace drain valve; software level: 2.23.Additional information received on 04feb2016 stated that the pump alarm showed "purge failure." the md used a spare device and informed the engineer.The engineer inspected the pump and confirmed drain valve malfunction.There was no reported patient death, injury, or complication.The patient outcome is listed as "well.".

Manufacturer Narrative

(b)(4) device evaluation: no parts or recorder strips were returned to teleflex (b)(4) for evaluation.A device history record (dhr) review was conducted for the intra-aortic balloon pump (iabp) serial and lot number with no relevant findings.The device passed all manufacturing specifications prior to release.A dhr review could not be conducted for the pneumatic control switch (pcs) assembly.The serial number and/or lot number was not documented.Conclusion: the report of "purge failure" is confirmed.The pump was checked by the engineer at the distributor.The drain valve of the pcs assembly malfunctioned and was replaced.The cause of the reported complaint could not be determined.

Event Description

It was reported per field service report: symptom - vacuum failure finding/action taken: replace drain valve software level: 2.23 additional information received on 04feb2016 stated that the pump alarm showed "purge failure." the md used a spare device and informed the engineer.The engineer inspected the pump and confirmed drain valve malfunction.There was no reported patient death, injury, or complication.The patient outcome is listed as "well.".

• Brand Name: AUTOCAT 2
• Type of Device: INTRA-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: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5416980
• MDR Text Key: 37740226
• Report Number: 1219856-2016-00039
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0400
• Other Device ID Number: 30801902051722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• 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: Unknown
• Patient Sequence Number: 1