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

Catalog Number IAP-0500

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report - (b)(4).Pump had purge failure alarm when first put on patient.Pump was switched out quickly without delay or impact to patient.Findings/actions taken: confirmed- pcs assembly replaced.Parts sent to and replaced by hospital biomed.Defective pcs assy.To be returned on (b)(4).Fcn level: 1416, software level: 2.24.

Manufacturer Narrative

Qn#(b)(4).The pcs assembly (p/n 96-3006-001, s/n (b)(4)) was returned for evaluation.Visual inspection of the pcs assembly was performed and no abnormality was found.The pcs assembly in question was installed into known good autocat2w and performed functional testing.The known good autocat2w with the pcs assembly in question installed passed the functional test.The purge cycle was performed multiple times with no alarms or errors.The pump was then left to run for over six hours without any issues.The pcs assembly in question was installed onto the mdt-50 leak tester and passed leak testing.Visual inspection of the pcs assembly internal hardware was performed and no abnormality was found.Per service history reported, the pcs assembly was replaced on november 22, 2005.A device history record (dhr) review was conducted for the iabp serial/ lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Other remarks: conclusion: the reported problem of purge failure alarm is not confirmed.The reported problem could not be reproduced during the functional test.The pcs assembly passed functional testing.The cause of the reported complaint is undetermined.

Event Description

It was reported via a field service report - l610990.Pump had purge failure alarm when first put on patient.Pump was switched out quickly without delay or impact to patient.Findings/actions taken: confirmed- pcs assembly replaced.Parts sent to and replaced by hospital biomed.Defective pcs assy.To be returned on (b)(4).Fcn level: 1416, software level: 2.24.

• Brand Name: AUTOCAT2 WAVE
• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5776377
• MDR Text Key: 49024824
• Report Number: 1219856-2016-00150
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: 0001055365
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2005
• 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