MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD NEONATAL SPECIALITY PACK BEQ-TOP 2202; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701062613

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Event Description

It was reported that prior to use of the neonatal speciality pack beq-top 2202 custom tubing pack it was noted that the connectors were missing.This was noted prior to patient use and therefore there was no patient involvement.

Event Description

It was reported that prior to use of the neonatal speciality pack beq-top 2202 custom tubing pack it was noted that the connectors were missing.This was noted prior to patient use and therefore there was no patient involvement.

Manufacturer Narrative

The investigation determined the customer ordered the requested device and all the attached parts as it was delivered, no nonconformances were found.The product was returned unused with all requested parts intact.The reported event cannot be confirmed by the evaluation.A device and lot history record review and trend evaluation was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).

• Brand Name: NEONATAL SPECIALITY PACK BEQ-TOP 2202
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8664011
• MDR Text Key: 146838747
• Report Number: 2248146-2019-00446
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2020
• Device Catalogue Number: 701062613
• Device Lot Number: 3000069806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1