MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problems Component Incompatible (1108); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) unit drive manifold was very noisy (ticking metal- like noise).There was no patient involvement.

Manufacturer Narrative

Additional customer contact information: name and email : (b)(6).Event site postal code: (b)(6).A getinge field service engineer evaluated during preventive maintenance confirmed drive manifold assy was very noisy (ticking metal-like noise) then fse replaced the drive manifold assembly.Repair and pm done, performed functional and safety checks.Unit cleared for clinical use and returned to customer.The defective components were received for further investigation.The failure analysis and testing dept.Received part with a reported unit failure of the assembly making a metal-like noise.The fat performed a visual inspection and found the part to be in good condition.The fat installed the drive manifold in cardiosave test fixture serial number and tested the part to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.Part passed the all manifold test.Then started to pump the iabp and noticed a loud metallic noise coming from the manifold.This persisted the whole time.Fat was able to verify the reported failure but no root cause identified.The supplier is not able to receive this part for failure analysis.Retaining the part in the failure analysis and testing department per procedure number (b)(4) rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• Brand Name: CARDIOSAVE HYBRID W/ E/F PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 15983199
• MDR Text Key: 306109938
• Report Number: 2249723-2022-03163
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: Other
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1