MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0500

Device Problem Low Battery (2584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pump was used on a patient and ran for ten minutes.After the alarm was set off, the pump shut off one minute later.As a result the battery was replaced.The field service tech performed functional checks and all functional checks passed.There was no report of patient complication or serious injury and death.The patient remains on the pump with error cleared.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "pump shut off approximately 1 minute" was confirmed by the field service engineer.The battery was replaced and the pump passed all functional checks.The root cause of the battery failure is undetermined.If the device is returned at a later date, a full investigation will be completed.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 assessed the risk for the reported complaint.There are no new or revised risks.The complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the pump was used on a patient and ran for ten minutes.After the alarm was set off, the pump shut off one minute later.As a result the battery was replaced.The field service tech performed functional checks and all functional checks passed.There was no report of patient complication or serious injury and death.The patient remains on the pump with error cleared.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7320228
• MDR Text Key: 101864310
• Report Number: 3010532612-2018-00041
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• 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