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

Catalog Number IAP-0500

Device Problem Gas Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). No sample components were received by manufacturer.

Event Description

It was reported via a hot line call the patient is (b)(6) tall. They placed the iab on the second cath lab procedure. The pump (b)(4) failed to restart related to pump valve controller failure. The registered nurse (rn) called the clinical support specialist to assist after she connected the fos to the second pump s/n (b)(4). The css walked the rn through changing connections from the first pump s/n (b)(4) to the second pump. There was a reported 10 minute delay. The pump is using the transducer and supporting the patient appropriately. The pump was to be flagged and sent to biomed with a note as to what the alarm said. The css received no further calls related to this patient.

Manufacturer Narrative

(b)(4). No parts or recorder strips were returned to teleflex (b)(4) for evaluation. Per the call report, the rn stated that the pump failed to restart (related to pump valve controller failure) after the patient required brief rounds of compressions. The pump was exchanged for a second pump and flagged to be sent to biomed. The hospitals biomed do their own repairs. They do not have a service contract. No service was provided to the pump. Additional information received from world wide support stated that this customer is a demand customer and a contract quote was given to them on (b)(6). No further information was received. No further action taken. A device history record (dhr) review was conducted for the iap lot/serial numbers with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of "alarm, system error 3" is not confirmed. The biomed department does their own repairs. No service was provided to the pump. No parts or recorder strips were returned to teleflex (b)(4) for evaluation. The cause of reported complaint is undetermined.

Event Description

It was reported via a hot line call the patient is 5'9" tall. They placed the iab on the second cath lab procedure. The pump (b)(4) failed to restart related to pump valve controller failure. The registered nurse (rn) called the clinical support specialist to assist after she connected the fos to the second pump s/n (b)(4). The css walked the rn through changing connections from the first pump s/n (b)(4) to the second pump. There was a reported 10 minute delay. The pump is using the transducer and supporting the patient appropriately. The pump was to be flagged and sent to biomed with a note as to what the alarm said. The css received no further calls related to this patient.

• 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: 6019045
• MDR Text Key: 57055158
• Report Number: 1219856-2016-00218
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K0603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/10/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0500
• Other Device ID Number: 30801902051715
• 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 Received: 10/19/2016
• 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